Company
GermanyBAYER PHARMA, AG, Berlin, Germany – FDA Inspections
Inspection records and compliance data for BAYER PHARMA, AG in Berlin. 10 FDA inspections on record, 2 Form 483s, last inspected June 06, 2024.
Company Profile
This profile covers BAYER PHARMA, AG based in Berlin, Germany.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 5
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 16, 2010. Last inspected June 6, 2024.
Most cited issue areas
- Cleaning System1 inspection
- Extent of discrepancy, failure investigations1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 6, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1282736 |
| August 27, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1239178 |
| September 24, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1102816 |
| July 3, 2017 | Not classified | Human Drugs | 1023408 |
| January 24, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1001127 |
| May 13, 2014 | VAI | Human Drugs · Drug Quality Assurance | 889209 |
| April 17, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 876478 |
| September 18, 2012 | VAI | Human Drugs · Drug Quality Assurance | 803657 |
| November 19, 2010 | NAI | Human Drugs · Drug Quality Assurance | 716641 |
| November 16, 2010 | NAI | Human Drugs · Bioresearch Monitoring | 704427 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
BAYER PHARMA, AG
FEI Number
3002808086
Address
Mullerstr. 170-178, Berlin, Germany
Country
Germany
ID: 28300a22-c506-4b1a-9052-6fc4e7170384