Company
GermanyBayer Bitterfeld GmbH, Bitterfeld-Wolfen, Germany – FDA Inspections
Inspection records and compliance data for Bayer Bitterfeld GmbH in Bitterfeld-Wolfen. 5 FDA inspections on record, 1 Form 483, last inspected June 19, 2024.
Company Profile
This profile covers Bayer Bitterfeld GmbH based in Bitterfeld-Wolfen, Germany.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 13, 2013. Last inspected June 19, 2024.
Most cited issue areas
- Backup file not maintained1 inspection
- Equipment Design, Size and Location1 inspection
- Following/documenting laboratory controls1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 19, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1272339 |
| July 10, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1124409 |
| March 23, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1048506 |
| April 8, 2016 | VAI | Human Drugs · Drug Quality Assurance | 967375 |
| December 13, 2013 | VAI | Human Drugs · Drug Quality Assurance | 887887 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bayer Bitterfeld GmbH
FEI Number
3003882513
Address
Salegaster Chaussee 1, Bitterfeld-Wolfen, Germany
Country
Germany
ID: 28df345a-0fc7-4c31-a91d-d6dea0535570