Request for Inspection Records of Bayer Facilities

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Reference: FDA1848635

Dear Requester,

This is to confirm that you submitted a request for record(s) from the Food and Drug Administration pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed; if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request. If your request is not sufficiently described, or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.

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Claire Tighe Claire Tighe
Re: Confirmation # FDA1848635
Requester Ctrl #:63574
In Reply refer to: 2018-9533
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
BAYER MEDICAL CARE, INDIANOLA, PA - INSPECTION RECS ETC
Original Subject: To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: A copy of all available documents on the FDA inspections at Bayer facilities for 1. pre-approval inspections and 2. inspections waiting for a final enforcement action. Facility addresses are as follows: PHI Bayer Medical Care, Inc. Indianola PA 15051-9702 PHI Bayer Medical Care, Inc. Saxonburg PA 16056-9772 NWJ Bayer Healthcare, LLC Morristown NJ 07960-4526 NWJ Bayer Healthcare Pharmac...
We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs change, and you no longer need the requested records, please contact us to cancel your request, as charges may be incurred once processing of your request has begun. For more information on processing fees, please see
http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm. If you have any questions about your request, please call Rochelle A. Coleman, Information Technician at (301) 796-8982 or write to us at: (http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm)
Division of Freedom of Information, U.S. Food and Drug Administration
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Ms. Tiche

Your FOIA Request was sent to my office and our Philadelphia Office for response.

To clarify

You are only looking for EIRs that were - preapproval inspections and inspections (EIRs) that are waiting final enforcement action?

Preapproval EIRs would most likely be releasable to you - EIR's awaiting a final enforcement action would not be publicly releasable.

Also - We need a time frame for your request.

If there are records available there definitely would be charges incurred.

Louise A. Miranda
Government Information Specialist
Office of Strategic Planning and Operational Policy
Information Disclosure Branch
louise.miranda@fda.hhs.gov

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Claire

Please respond to my email (attached). If we do not hear from you by 12/14/18 your request will be closed to the NJ Office (Bayer Morristown and Whippany, NJ)

Thank you for your anticipate response.

Louise A. Miranda
Government Information Specialist
Office of Strategic Planning and Operational Policy
Information Disclosure Branch
louise.miranda@fda.hhs.gov

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Good afternoon,

Attached is the response letter from the New Jersey District Office regarding your FOIA Request 2018-9533.

Thank you,

Wilson M. Russ
Government Information Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8981
wilson.russ@fda.hhs.gov<mailto:wilson.russ@fda.hhs.gov>

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