Bayer Inspection Records at Westhaven Facility

Claire Tighe filed this request with the Food and Drug Administration of the United States of America.
Tracking #

FDA1848636

Est. Completion None
Status
Fix Required

Communications

From: Claire Tighe


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 for BIORESEARCH MONITORING, at Bayer facilities for nonclinical laboratories in good standing,

Facility address is as follows:

Bayer HealthCare Pharmaceuticals Inc West Haven CT 06516-4140

The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Sincerely,

Claire Tighe

From: Food and Drug Administration

*** This is an automated message. Please do not reply to this email. ***

Reference: FDA1848636

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.

From: Food and Drug Administration

Note: Do NOT reply directly to this E-mail
Claire Tighe requests@muckrock.com
Re: Confirmation # FDA1848636
Requester Ctrl #:63575
In Reply refer to: 2018-9522
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
BAYER HEALTHCARE PHARMACEUTICALS INC, WEST HAVEN, CT - INSPECTION RECS
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 for BIORESEARCH MONITORING, at Bayer facilities for nonclinical laboratories in good standing, Facility address is as follows: Bayer HealthCare Pharmaceuticals Inc West Haven CT 06516-4140 The requested documents will be made available to the general public, and this request is not being made for commercial purposes. In the eve...
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
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Fax:(301)827-9267
You also have the right to seek dispute resolution services from:
FDA FOIA Public Liaison
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov and/or:
Office of Government Information Services
National Archives and Administration
8601 Adelphi Road ? OGIS
College Park, MD 20740-6001
Telephone: 202-741-5770
Toll-Free: 1-877-684-6448
E-mail: ogis@nara.gov
Fax: 202-741-5769

From: Food and Drug Administration

I am in receipt of the above FOI request. Below is a link that will provide you with information on the fees
Involved with filing an FOI request.

Please note that your request letter does not provide a time frame and therefore this could
lead to a search back 10 years of records.

Please note that that this search could estimate charges of over $500.00.

Please let me know if you would like for me to continue the review of this request.

https://www.fda.gov/regulatoryinformation/foi/howtomakeafoiarequest/default.htm

Barbara A. Recupero
Government Information Specialist
FDA - Office of Strategic Planning and Operation Policy
Division of Information Disclosure
781-587-7482
Barbara.recupero@fda.hhs.gov<mailto:Barbara.recupero@fda.hhs.gov>

From: Claire Tighe

Hello,

The requested documents will be made available to the general public, and this request is not being made for commercial purposes. I am also affilaited with New York University, so I do not believe there should be fees associated.

The time frame requested is January 1, 2016 to June 30, 2018.

Thank you.

From: Muckrock Staff

To Whom It May Concern:
I wanted to follow up on the following request, copied below. Please let me know when I can expect to receive a response.
Thanks for your help, and let me know if further clarification is needed.

From: Food and Drug Administration

Please see email in regards to the above subject request. Request
was cancelled when there was no receipt of response regarding the email
below. A new request will need to be filed with additional information in regards to the time frame
of search.

Barbara A. Recupero
Government Information Specialist
FDA - Office of Strategic Planning and Operation Policy
Division of Information Disclosure
781-587-7482
Barbara.recupero@fda.hhs.gov<mailto:Barbara.recupero@fda.hhs.gov>

Files

There are no files associated with this request.