Request for Inspection Records of Bayer Facilities
It is a clone of this request.
| Tracking # |
2018-9519 FDA1848634 |
| Submitted | Nov. 9, 2018 |
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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 at the following facilities, as per the publicly available information from the Inspection Classification Database:
PHI Bayer Medical Care, Inc. Pittsburgh PA 15238-2819 US Jan-27-2011 Postmarket Assurance: Devices NAI CDRH
PHI Bayer Medical Care, Inc. Indianola PA 15051-9702 US Feb-03-2011 Postmarket Assurance: Devices OAI CDRH
SAN Bayer Healthcare, LLC Milpitas CA 95035-7920 US Jun-26-2013 Postmarket Assurance: Devices NAI CDRH
PHI Bayer Medical Care, Inc. Pittsburgh PA 15238-2819 US Aug-01-2013 Postmarket Assurance: Devices NAI CDRH
PHI Bayer Medical Care, Inc. Indianola PA 15051-9702 US Aug-23-2011 Postmarket Assurance: Devices NAI CDRH
SAN Bayer Healthcare, LLC Milpitas CA 95035-7920 US Jan-06-2011 Postmarket Assurance: Devices VAI CDRH
PHI Bayer Medical Care, Inc. Saxonburg PA 16056-9772 US Aug-07-2013 Postmarket Assurance: Devices NAI CDRH
PHI Bayer Medical Care, Inc. Pittsburgh PA 15238-2819 US Jan-18-2017 Postmarket Assurance: Devices NAI CDRH
PHI Bayer Medical Care, Inc. Indianola PA 15051-9702 US Jan-06-2017 Postmarket Assurance: Devices NAI CDRH
PHI Bayer Medical Care, Inc. Indianola PA 15051-9702 US Aug-12-2013 Postmarket Assurance: Devices NAI CDRH
PHI Bayer Medical Care, Inc. Saxonburg PA 16056-9772 US Jan-14-2011 Postmarket Assurance: Devices NAI CDRH
PHI Bayer Medical Care, Inc. Saxonburg PA 16056-9772 US Jan-19-2017 Postmarket Assurance: Devices NAI CDRH
NWJ Bayer Healthcare, LLC Morristown NJ 07960-4526 US Sep-10-2010 Postmarket Surv. and Epidemiology VAI CDER
NWJ Bayer Healthcare Pharmaceuticals Inc. Whippany NJ 07981-1544 US Aug-09-2018 Postmarket Surv. and Epidemiology NAI CDER
SAN Bayer Healthcare, LLC Milpitas CA 95035-7920 US Jul-01-2015 Project Evaluation: Devices NAI CDRH
PHI Bayer Medical Care, Inc. Pittsburgh PA 15238-2819 US Aug-17-2018 Radiation Control and Health Safety Act NAI CDRH
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: FDA1848634
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 Claire Tighe
Re: Confirmation # FDA1848634
Requester Ctrl #:63573
In Reply refer to: 2018-9519
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
BAYER INSPECTION RECS
Original Subject: See attached letter for request.
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.
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
A copy of documents responsive to the request.
From: Food and Drug Administration
A cover letter granting the request and outlining any exempted materials, if any.
From:
Attached is the NJ Queue response to the subject FOIA. Pls acknowledge receipt of this email and attachment. Thank you!
Louise A. Miranda
Government Information Specialist
Office of Strategic Planning and Operational Policy
Information Disclosure Branch
louise.miranda@fda.hhs.gov
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Ms. Tighe
Attached is the NJ Office response to the subject FOIA. Pls acknowledge receipt of this email and attachments. Thank you.
Louise A. Miranda
Government Information Specialist
Office of Strategic Planning and Operational Policy
Information Disclosure Branch
louise.miranda@fda.hhs.gov
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Claire Tighe
Thank you. I will review and follow up with any questions.
From: Food and Drug Administration
Hello,
Please see the attached response letter and enclosures to your FOI request 2018-9519 for the San Francisco Office responsive portion of your request.
If you could, please confirm receipt of this email and the 11 attachments.
Thank you.
Sincerely,
Jason Schilling, MBA
Government Information Specialist
FOIA West (Branch II)
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning and Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U. S. Food and Drug Administration
4040 N. Central Expressway, Ste. 300
Dallas, TX 75204
Office: 214-253-5262
Fax: 214-253-5314
Jason.Schilling@fda.hhs.gov<mailto:Jason.Schilling@fda.hhs.gov>
[cid:image001.png@01D20E70.82D77510]<http://www.fda.gov/>
[cid:image002.jpg@01D20E70.82D77510]<https://www.facebook.com/FDA> [cid:image003.jpg@01D20E70.82D77510] <https://twitter.com/US_FDA> [cid:image004.jpg@01D20E70.82D77510] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D20E70.82D77510] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D20E70.82D77510] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
This message is intended for the exclusive use of the recipient(s) named above. It may contain Non Public Information that is proprietary, protected, privileged, or confidential, and should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this message in error, please delete all copies of this message & notify the sender immediately at jason.schilling@fda.hhs.gov<mailto:jason.schilling@fda.hhs.gov>
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From: Claire Tighe
Thank you. I will review and follow up with any questions.
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