Mandatory View Using MedWatch Plus Rational Questionnaire

Electronic Data Collection Using MedWatchPlus Portal and Rational Questionnaire--21 CFR 310.305, 314.80, 314.98, 514.80, 600.80, 1271.350 and Part 803

Confidential 1005_Mandatory-Initial-Part_4-Adulteration_Origination_Site-040109 (2)

Mandatory View Using MedWatch Plus Rational Questionnaire

OMB: 0910-0645

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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
þPRODUCT PROBLEM
SUMMARY

ADULTERATION ORIGINATION SITE INFORMATION
You indicated that the adulteration origination site is the site named below. We appreciate any additional
information you might have about the adulteration origination site to help us in the investigation.
For the purposes of this report, the Food (or Feed) Facility and the Adulteration Origination Site are
not the same and the reporter indicated in the subview questions that they knew the name of the
AOS. Therefore, this section is presented for any additional information the reporter might have.
1. Adulteration Origination Site Name:*
Name Piped in From Subview Questions/Editable
[7304/16019]

2. Country of Residence: Drop down of countries. Assume USA for this draft.
[7310/16025]

þ Problem Description

3. Street Address:

Open Text

[7305/16020]
[7306/16021]

Open Text

o ADULTERATION ORIGINATION
SITE INFO

4. City/Town:

Open Text

oSUPPLEMENTAL DOCUMENTS

5. State: Drop down of states

oSUBMIT REPORT

6. Zip Code:

þ Additional Info

If USA, the labels will be State & Zip
Code; Otherwise, labels will be State/
Province or similar (open text) and
Postal Code. Zip code look up will be
considered for a later release.

[41/9305]
[7307/16022]
Numeric

[7309/16024]

If country is not U.S., Contact info will be for U.S. Agent ( labels will reflect this)
7. Title of Site Contact Person:

Open Text

[7311/16026]

8. First Name of Site Contact Person:

Open Text

[7313/16028]

9. Last Name of Site Contact Person:

Open Text

[7312/16027]

10. Email Address of Site Contact Person:

Open Text

[7317/16032]

11. Primary Phone:
[7314/16029]
Report Created:
Today’s Date:
Report Status:
Reporter:

03-24-2009
03-25-2009
In progress
Sandy Daston

numeric
Area code

12. Other Phone

numeric

[7315/16030]

Area code

13. Fax

numeric

[7316/16031]

Area code

1005 Mandatory-Part 1– Adulteration Origination Site– Initial Report —040109

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numeric

Extension:

numeric

Extension:

numeric

Phone Number

numeric

numeric

Phone Number

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numeric

Phone Number

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File Typeapplication/pdf
File Title1005_Mandatory-Initial-Part_4-Adulteration_Origination_Site-040109_4842534.pub
AuthorAdministrator
File Modified2009-05-26
File Created2009-04-07

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