Company
United StatesBayer Medical Care, Inc., Indianola, PA – FDA Inspections
Inspection records and compliance data for Bayer Medical Care, Inc. in Indianola, Pennsylvania. 6 FDA inspections on record (1 OAI), 1 Form 483, last inspected September 07, 2018.
Company Profile
This profile covers Bayer Medical Care, Inc. based in Indianola, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 0
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 3, 2011. Last inspected September 7, 2018.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 7, 2018 | Not classified | Medical Devices & Rad Health | 1123891 |
| January 6, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1006762 |
| August 12, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 844196 |
| May 2, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 781646 |
| August 23, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 741066 |
| February 3, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 706708 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bayer Medical Care, Inc.
FEI Number
2520313
Address
1 Bayer Dr, Indianola, Pennsylvania 15051, United States
Country
United States
ID: 5564ee53-b177-4d02-b440-2084714f6daf