FDA Inspection
GBA Pharma GmbHGBA Pharma GmbH – FDA Inspection, Oct 12, 2018
Record Details
This FDA Inspection record concerns GBA Pharma GmbH, with an inspection on October 12, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 30ffd245-ccb0-457d-95fe-52465980c28e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070434
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of GBA Pharma GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2024 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| October 18, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 14, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for GBA Pharma GmbH
- FDA Inspection 1261571 - 2024-12-11
- FDA Inspection 865034 - 2013-10-18
- FDA Inspection 607366 - 2009-07-14
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