FDA Inspection
GP Grenzach Produktions GmbHGP Grenzach Produktions GmbH – FDA Inspection, Jan 30, 2018
Record Details
This FDA Inspection record concerns GP Grenzach Produktions GmbH, with an inspection on January 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 286976b2-5b2a-4ff9-a8d2-81edec693efd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039362
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.113(b)Validation lacking for sterile drug products
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Other FDA inspections of GP Grenzach Produktions GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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