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pdfThis document contains confidential deliberative information.
REPORT VIEW: 1005 (Mandatory)
REPORTER TYPE:
Responsible Party
REPORT TYPE: Initial
þINTRODUCTION
þRESPONSIBLE PARTY INFO
SUMMARY OF PRODUCT PROBLEM
This section asks for a summary of the product problem including how and when you learned about the
problem, information about suspect products (received or produced), and a description of the problem.
If you have additional details about any of the suspect products, you will be asked to provide them so that
we can move to resolve the problem in a timely fashion. If you do not have any details at this time, you
submit them on follow up report.
þFOOD/FEED FACILITY INFO
oPRODUCT PROBLEM SUMMARY
oProblem Description
oAdditional Info
oADULTERATION ORIGINATION
SITE INFO
oSUPPLEMENTAL DOCUMENTS
oSUBMIT REPORT
IMPORTANT: To take the next step, notifying sites that you received suspect products from or distributed
products to, you must have an FDA-supplied report ID. At the end of this section, instructions will be
provided about how to submit this initial report and about the next steps for required reporting.
Description of the Product Problem
1. Date/time your site learned about the product problem:* [960/9255]
Date:
DD
YYYY
MM
Suggest drop down for MM and DD and open text field for YYYY when date is requested.
2. How your site first learn about the product problem:* [14.4/9272]
m Notified by another firm in the supply chain (show 2a)
m Self discovery or Other (show 2b)
This is how we will handle the “other” option for R1. We can analyze and see if it is worth the effort
for R2 or later
The FDA is providing better wording/definitions for self-discovery so that the meaning is clear.
.
Report Created:
Today’s Date:
Report Status:
Reporter:
03-24-2009
03-25-2009
In progress
Sandy Daston
1005 Mandatory-Part 3– Summary of Product Problem– Initial Report —040109
1
This document contains confidential deliberative information.
REPORT VIEW: 1005 (Mandatory)
REPORTER TYPE:
Responsible Party
REPORT TYPE: Initial
SUMMARY OF PRODUCT PROBLEM (continued)
Description of the Product Problem (cont’)
þINTRODUCTION
If notified by another firm, show 2 a. There must be at least one firm in 2a.
2a. Who notified you? List all the sites that notified you about the product problem and indicate the
involved product that they reported and their relationship to your Food/Feed Facility in the supply chain.
þRESPONSIBLE PARTY INFO
þFOOD/FEED FACILITY INFO
Other Firm/Site Info(*)
Suspect/Involved Products
[2028/16090]???
Relationship in the
Supply Chain (*)
[see name field]
Product Name 1
m Received
oPRODUCT PROBLEM SUMMARY
oProblem Description
oAdditional Info
oADULTERATION ORIGINATION
SITE INFO
oSUPPLEMENTAL DOCUMENTS
Site Name [7104/9288]-from
[7004/9276]-to
SITE 1
ADD ANOTHER PRODUCT
products from site
m Distributed
products to site
Other Site FDA-Issued Report ID
If more than one suspect product,
then the reporter can click to add
more; the list would grow
[601.1/13059]
ICSR NUMBER
oSUBMIT REPORT
Site Name [7104/9288]-from
Product Name 2
[7004/9276]-to
SITE 2
ADD ANOTHER PRODUCT
Other Site FDA-Issued Report ID
m Received
products from site
m Distributed
products to site
DELETE
SITE
[601.1/13059]
ICSR NUMBER
CLICK TO ADD ANOTHER SITE
The ICSR Number is optional for this initial report but may be mandatory for follow up reports
If self discovery or other, show 2 b
2b. How your site learned bout the problem. (*) In the space below, describe how your site learned that
there was a reportable food/feed problem. [include with product problem narrative]
Report Created:
Today’s Date:
Report Status:
Reporter:
03-24-2009
03-25-2009
In progress
Sandy Daston
1005 Mandatory-Part 3– Summary of Product Problem– Initial Report —040109
Open Text
2
This document contains confidential deliberative information.
REPORT VIEW: 1005 (Mandatory)
REPORTER TYPE:
Responsible Party
REPORT TYPE: Initial
þINTRODUCTION
þRESPONSIBLE PARTY INFO
þFOOD/FEED FACILITY INFO
oPRODUCT PROBLEM
SUMMARY
oProblem Description
oAdditional Info
SUMMARY OF PRODUCT PROBLEM (continued)
Description of the Product Problem (cont’)
3. Reportable Food/Feed Product(s). List the reportable food or feed products that you are aware of; that
is, the food(s) or feed(s) that are currently suspect even if you do not know the cause of the adulteration or
what it is about the food or ingredient that may be causing the problem. These may be products that you
have received or that you have produced or distributed. Include both the Product Name and Brand Name in
the Product Name Field. For the container type and size of container, the product is defined as the smallest
amount for retail sale or further distribution. Please provide as much information as is available.
If 2=self discovery or other OR if 2a does not include notification about received products, show 3a.
Otherwise, automatically show the table, prefilling any previously provided information
3a. Did you receive any reportable food/feed products? m Yes m No m Don’t Know [screener-no ID]
If yes, show table below. Only Product Name & Received From is required.
RECEIVED PRODUCTS—If you provided information previously about received products, the information
appears below for your convenience.
oADULTERATION ORIGINATION
SITE INFO
oSUPPLEMENTAL DOCUMENTS
oSUBMIT REPORT
Received Product Information
Product Name: (*)
Open Text or Product Name Text Piped from 2a
[2028/16090]???
Received from:(*)
[7104/9288]
Open Text or Site Name (ICSR#) Piped from 2a
Open Text
UPC: [####/9301]
FDA Action Items 1) to provide better wording and instructions with
regard to what is wanted for package name and size 2) Also, the IDs
for Product Name are unclear. Do
they refer to Products Received or
produced.
Pkg Category:
DELETE
PRODUCT
m Bulk m Retail m Institutional
1017.1/13046]
Container type: Drop down list of values Container Size numeric UOM Drop down
[1018/9297]
[1016/13040] [1016.1/13041]
Total Containers Received:
[7121/13043]
numeric
Total Amt Received:
numeric
UOM Drop down
[7119/16012]
CLICK TO ADD ANOTHER PRODUCT
Report Created:
Today’s Date:
Report Status:
Reporter:
03-24-2009
03-25-2009
In progress
Sandy Daston
Info provided in 2a about site name and product would be piped in, if available, but would be editable
(validations would occur to ensure edits make for consistent info). Reporter can add additional
suspect products received that they had not been notified about. If the user says “yes” to 3a OR
has been notified about a received product as indicated in 2a, at least one product must appear in
the table. The products they have been notified about cannot be deleted. Products that they add (no
notification) can be deleted. The delete button is shown here as a function, but a single product
would not be deletable. Any empty rows would be deleted upon save.
1005 Mandatory-Part 3– Summary of Product Problem– Initial Report —040109
3
This document contains confidential deliberative information.
REPORT VIEW: 1005 (Mandatory)
REPORTER TYPE:
Responsible Party
REPORT TYPE: Initial
SUMMARY OF PRODUCT PROBLEM (continued)
Description of the Product Problem (cont’)
The functionality for produced products will work much the same way as for 3a related to piping and
editing of product name (reporter can edit and delete the product names any time prior to submitting
the initial report).
þINTRODUCTION
þRESPONSIBLE PARTY INFO
þFOOD/FEED FACILITY INFO
oPRODUCT PROBLEM
SUMMARY
oProblem Description
oAdditional Info
oADULTERATION ORIGINATION
SITE INFO
If the reporter indicates in 2a that they were notified by a site to which they had distributed,
automatically show the 3b table. Otherwise, ask the 3 b screener (this applies to those who answer
“Self discovery or Other in question 2).
3b. Did your site produce/repackage for distribution a reportable food product?
m Yes m No m Don’t Know [screener-no ID]
If yes, show table below. Only Product Name is required.
Manufactured or RePackaged/Distributed Product Information
Product Name: (*)
Open Text or Product Name Text Piped from 2a
[2028/16090]???
oSUPPLEMENTAL DOCUMENTS
UPC: [####/9301]
oSUBMIT REPORT
Pkg Category:
Open Text
m Bulk m Retail m Institutional
1017.1/13046]
Container type: Drop down list of values Container Size numeric UOM Drop down
[1018/9297]
[1016/13040] [1016.1/13041]
FDA Action Items 1) to provide better wording and instructions with
regard to what is wanted for package name and size 2) Also, the IDs
for Product Name are unclear. Do
they refer to Products Received or
produced.
Total Containers Produced:
numeric
Product Name: (*)
UOM Drop down
Open Text or Product Name Text Piped from 2a
[2028/16090]???
Pkg Category:
numeric
[[1061.3/9267] [1061.4/13058]
[1061.2/9267]
UPC: [####]
Total Amt Produced:
Open Text
m Bulk m Retail m Institutional
1017.1/13046]
Container type: Drop down list of values Container Size
[1018/9297]
[1016/13040]
Report Created:
Today’s Date:
Report Status:
Reporter:
03-24-2009
03-25-2009
In progress
Sandy Daston
Total Containers Produced:
numeric
Total Amt Produced:
numeric
UOM Drop down
[1016.1/13041]
numeric
DELETE
PRODUCT
UOM Drop down
[[1061.3/9267] [1061.4/13058]
[1061.2/9267]
CLICK TO ADD ANOTHER PRODUCT
1005 Mandatory-Part 3– Summary of Product Problem– Initial Report —040109
4
This document contains confidential deliberative information.
REPORT VIEW: 1005 (Mandatory)
REPORTER TYPE:
Responsible Party
REPORT TYPE: Initial
þINTRODUCTION
þRESPONSIBLE PARTY INFO
SUMMARY OF PRODUCT PROBLEM (continued)
Description of the Product Problem (cont’)
4. Product Problem Narrative:* [14/9271] Text boxes would be concatenated; something must appear
in at least one text box.
a. Describe the problem-including what the adulteration is, how it happened/any contributing
factors, and how long this problem has been occurring. If known, specify if biological, physical,
radiological or chemical adulteration.
þFOOD/FEED FACILITY INFO
oPRODUCT PROBLEM
SUMMARY
Open Text
b. Describe any investigations in progress and any available investigation results.
oProblem Description
oAdditional Info
oADULTERATION ORIGINATION
SITE INFO
Open Text
c. Describe the current status—including what is being done to contain or dispose of any affected
products.
Open Text
oSUPPLEMENTAL DOCUMENTS
oSUBMIT REPORT
d. Other relevant details — use the space below to tell us about any other pertinent details
Open Text
FDA Action Items : Please review
the breakdown in #4 Problem Narrative and provide any edits to categories. These will be all be concatenated in the final message. They
are to assist the user in providing
the relevant information.
Report Created:
Today’s Date:
Report Status:
Reporter:
03-24-2009
03-25-2009
In progress
Sandy Daston
5. Do you believe the suspect product was intentionally adulterated?* [2028.2/9254]
m Yes m No m Unknown
6. Related adverse events reported to your site?* [screener-no id]
m Yes m No m Unknown
If yes, show 6a
6a. Types of adverse events reported: (*) (check all that apply) [14.5 &14.61/9272]
q Human Adverse Events (show 6a.1)
q Animal Adverse Events (show 6a.2)
6a.1 (*) Describe the human adverse events—including affected individuals, symptoms, lab
results, date/time of onset relative to product consumption. [N65/15997]
Open Text
6a.2 (*) Describe the animal adverse events—including affected animals, symptoms, lab results,
date/time of onset relative to product consumption. [N64/15993]
Open Text
1005 Mandatory-Part 3– Summary of Product Problem– Initial Report —040109
5
This document contains confidential deliberative information.
REPORT VIEW: 1005 (Mandatory)
REPORTER TYPE:
Responsible Party
REPORT TYPE: Initial
þINTRODUCTION
þRESPONSIBLE PARTY INFO
þFOOD/FEED FACILITY INFO
oPRODUCT PROBLEM
SUMMARY
þProblem Description
SUMMARY OF PRODUCT PROBLEM (continued)
Additional Information About Suspect Products Received or Produced
Types of information that will be helpful in the investigation appear in the box below. Any additional
information that you can provide at this time will be helpful. You need not provide all listed info.
Products Received Information
• Lot Numbers/Manufacturer IDs
• Expiration or Use-by Dates
• Product imported?
• Receipt Dates
• Method/details of product disposal
• Contact information for Source Sites
Products Produced/Repackaged Info
• Lot Numbers/Manufacturer IDs
• Expiration or Use-by Dates
• Method/details of product disposal
• Amounts distributed
• Distribution sites & dates distributed
oAdditional Info
oADULTERATION ORIGINATION
SITE INFO
1. You indicated you received or distributed the following products. Can you provide any of the
above information for these products at this time?* [screener-no ID]
PRODUCTS RECEIVED
oSUPPLEMENTAL DOCUMENTS
oSUBMIT REPORT
Information Already Provided
Able to provide more
info?
(as listed above)
Piped in info for product received #1 from table on pg 3
m Yes
m No
Piped in info for product received #2 from table on pg 3
m Yes
m No
Piped in info for product received #n from table on pg 3
m Yes
m No
PRODUCTS PRODUCED/REPACKAGED
Information Already Provided
Report Created:
Today’s Date:
Report Status:
Reporter:
03-24-2009
03-25-2009
In progress
Sandy Daston
Able to provide more
info?
(as listed above)
Piped in info for “new” product #1 from table on pg 4
m Yes
m No
Piped in info for “new” product #2 from table on pg 4
m Yes
m No
Piped in info for “new” product #n from table on pg 4
m Yes
m No
For all yes, answers, the reporter would be given additional forms to complete as on the next
two pages.
1005 Mandatory-Part 3– Summary of Product Problem– Initial Report —040109
6
This document contains confidential deliberative information.
REPORT VIEW: 1005 (Mandatory)
REPORTER TYPE:
Responsible Party
REPORT TYPE: Initial
þINTRODUCTION
þRESPONSIBLE PARTY INFO
SUMMARY OF PRODUCT PROBLEM (continued)
Additional Information About Suspect Products Received
Thank you for providing additional information about one or more suspect products received. A summary of
information you have already given for each product appears below. We appreciate your filling in as much
of the other information as you can.
Product name and site name would be piped in for each product. The chart would repeat for all
products received for which the reporter indicates he/she can provide more info.
þFOOD/FEED FACILITY INFO
oPRODUCT PROBLEM
SUMMARY
þProblem Description
oAdditional Info
oADULTERATION ORIGINATION
SITE INFO
oSUPPLEMENTAL DOCUMENTS
oSUBMIT REPORT
Product Name Received from Site Name
Summary of information already provided: (Information filled in as an example)
•
•
•
UPC: 1234
Site notified you? Yes
Pkg category: Not provided
•
•
•
Container type: Can
Container Size: 12 ounces
# Containers Rec’d: 144
•
Total Amt Received: 1728
ounces
Click to edit this info
Information About the Site From Which the Product Was Received
1.Type of Site: (Check all that apply)
q Acidified Food Processor
q Caterer/Catering Point
q Certified Shellfish Establishment
q Commissary
q Contract Sterilizer
q Labeler/Relabeler
q Low Acid Canned Processor
q Manufacturer
q
q
q
q
q
q
q
Own Label Distributor
Repacker/Packer
Salvage Operation
Shipper
Warehouse-Ambient Storage
Warehouse-Frozen Storage
Warehouse-Refrigerated Storage
Source Site Location & Contact Information
2.Country Drop Down Select—assume U.S.
3.Street Address
Open Text
Open Text
4. City
Report Created:
Today’s Date:
Report Status:
Reporter:
03-24-2009
03-25-2009
In progress
Sandy Daston
Open Text
7. Contact Person Title
Open Text
8. Contact First Name
Open Text
9. Contact Last Name
Open Text
10. Email Address
Open Text
11. Primary Phone
5. State Drop Down Select
6. Zip Code
1005 Mandatory-Part 3– Summary of Product Problem– Initial Report —040109
Numeric
12. Other Phone
13. Fax
numeric
numeric
numeric
numeric
numeric
numeric
numeric
numeric
numeric
7
This document contains confidential deliberative information.
REPORT VIEW: 1005 (Mandatory)
REPORTER TYPE:
Responsible Party
REPORT TYPE: Initial
SUMMARY OF PRODUCT PROBLEM (continued)
Additional Information About Suspect Products Received (continued)
On the web page, this would be contiguous (one page) with the form on page 7.
Product Name Received from Site Name (continued)
þINTRODUCTION
Information About the Product
þRESPONSIBLE PARTY INFO
þFOOD/FEED FACILITY INFO
oPRODUCT PROBLEM
SUMMARY
þProblem Description
oAdditional Info
oADULTERATION ORIGINATION
SITE INFO
oSUPPLEMENTAL DOCUMENTS
oSUBMIT REPORT
14. Was product imported? m Yes m No m Unknown
If yes, show 14a
14a. Port of entry: Drop down select
15. Product recalled? m Yes m No m Unknown
If yes, show 15a
15a. Recall #:
Open Text
16. Number of Lots or Batches of Product Received:
Lots or batches are defined as ……
Integer
FDA to provide a definition of lot or batch that reporter will be able to complete & still provide
meaning for the report itself.
Please provide as much information as you can for each suspect lot or batch received, by lot or batch. If you do not
have the information, leave it blank. A form would be provided for each lot indicated in #16 above
INFORMATION FOR LOT 1
17. Lot # or ID:
Open Text
18. Expiration/
Use-by Date:
MM/YYYY
19. # Containers Rec’d:
20. Total Amt
Received:
Report Created:
Today’s Date:
Report Status:
Reporter:
03-24-2009
03-25-2009
In progress
Sandy Daston
Numeric
Integer
UOM drop down
21. First Receipt Date
MM/DD/YYYY
22. Last Receipt Date:
MM/DD/YYYY
May be the same as First
Receipt date.
23. Disposed as Received? (All or Part)
m Yes m No m Unknown
If yes, show 23 a through d
23a. Disposal Date:
MM/DD/YYYY
23b: # Containers Disposed:
23c: Total Amt
Disposed:
Numeric
Integer
UOM drop down
23d: Method of Disposal (check all that apply)
q Destroyed q Reconditioned
q Diverted to Animal Food
q Other q Unknown
NOTE: On the follow up form, after the ICSR # is obtained, the following questions will appear for sites
that did not notify the reporting site. “Did you notify this site?” If yes, “Date of notification”
1005 Mandatory-Part 3– Summary of Product Problem– Initial Report —040109
8
This document contains confidential deliberative information.
REPORT VIEW: 1005 (Mandatory)
REPORTER TYPE:
Responsible Party
REPORT TYPE: Initial
þINTRODUCTION
þRESPONSIBLE PARTY INFO
SUMMARY OF PRODUCT PROBLEM (continued)
Additional Information About Suspect Products Produced/Repackaged
Thank you for providing additional information about one or more suspect products produced or repackaged
for distribution by your site A summary of information you have already given for each product appears
below. We appreciate your filling in as much of the other information as you can.
Product name would be piped in for each product. The chart would repeat for all products produced/
repackaged for which the reporter indicates he/she can provide more info.
þFOOD/FEED FACILITY INFO
oPRODUCT PROBLEM
SUMMARY
þProblem Description
oAdditional Info
oADULTERATION ORIGINATION
SITE INFO
Product Name Information
Summary of information already provided: (Information filled in as an example)
•
•
•
•
•
•
UPC: 1234
Pkg category: Retail
Container type: Can
Container Size: 12 ounces
# Containers Produced: 144
Total Amt Produced: 1728 ounces
Click to edit this info
oSUPPLEMENTAL DOCUMENTS
oSUBMIT REPORT
1. Number of Lots or Batches of Suspect Product Produced:
Lots or batches are defined as ……
Integer
FDA to provide a definition of lot or batch that reporter will be able to complete & still provide meaning for the report itself.
Please provide as much information as you can for each suspect lot or batch received, by lot or batch. If you do not
have the information, leave it blank. A form would be provided for each lot indicated in #1 above
INFORMATION FOR LOT 1
2. Lot # or ID:
Open Text
3. Expiration/Use
-by Date:
MM/YYYY
4. # Containers Produced:
5. Total Amt
Produced:
Report Created:
Today’s Date:
Report Status:
Reporter:
03-24-2009
03-25-2009
In progress
Sandy Daston
7. Disposed as Produced? (All or Part)
m Yes m No m Unknown
If yes, show 7 a through d
7a. Disposal Date:
MM/DD/YYYY
Numeric
Integer
UOM drop down
6. Distributed to other sites?
m Yes m No m Unknown
If yes, show 6a and 8 through 22
6a. # of sites distributed to:
1005 Mandatory-Part 3– Summary of Product Problem– Initial Report —040109
Integer
7b: # Containers Disposed:
7c: Total Amt
Disposed:
Numeric
Integer
UOM drop down
7d: Method of Disposal (check all that apply)
q Destroyed q Reconditioned
q Diverted to Animal Food
q Other q Unknown
9
This document contains confidential deliberative information.
REPORT VIEW: 1005 (Mandatory)
REPORTER TYPE:
Responsible Party
REPORT TYPE: Initial
SUMMARY OF PRODUCT PROBLEM (continued)
Additional Information About Suspect Products Produced/Repackaged (cont’)
On the web page, this would be contiguous (one page) with the form on page 9.
Product Name Information (continued)
þINTRODUCTION
þRESPONSIBLE PARTY INFO
þFOOD/FEED FACILITY INFO
LOT 1 INFORMATION (continued)
The reporter would be provided with a separate form for each distribution site indicated.
oPRODUCT PROBLEM
SUMMARY
Please provide as much information as you have for the sites you distributed this product to.
DISTRIBUTION SITE 1
þProblem Description
oAdditional Info
oADULTERATION ORIGINATION
SITE INFO
oSUPPLEMENTAL DOCUMENTS
oSUBMIT REPORT
8. Name of Site:
16. Contact Person Title
Open Text
9. Container Qty Distributed:
Integer
10. Total Amt Distributed: Numeric
UOM drop down
Open Text
17. Contact First Name
Open Text
18. Contact Last Name
Open Text
19. Email Address
Distribution Contact & Location Information
20. Primary Phone
11.Country Drop Down Select—assume U.S.
21. Other Phone
12.Street Address
22. Fax
Open Text
Open Text
numeric
numeric
numeric
numeric
numeric
numeric
numeric
numeric
numeric
Open Text
13. City
Open Text
14. State
Drop Down Select
15. Zip Code
Report Created:
Today’s Date:
Report Status:
Reporter:
03-24-2009
03-25-2009
In progress
Sandy Daston
Numeric
NOTE: On the follow up form, after the ICSR # is obtained, the following questions will appear for sites
that did not notify the reporting site. “Did you notify this site?” If yes, “Date of notification”
Response options should be: Yes; No, but they notified our site; No and they did not notify our site.
1005 Mandatory-Part 3– Summary of Product Problem– Initial Report —040109
10
| File Type | application/pdf |
| File Title | 1005_Mandatory-Initial-Part_3-Problem_Summary-040109_4155463.pub |
| Author | Administrator |
| File Modified | 2009-05-26 |
| File Created | 2009-04-10 |