FDA Inspection
Ansynth Service BVAnsynth Service BV – FDA Inspection, Apr 24, 2019
Record Details
This FDA Inspection record concerns Ansynth Service BV, with an inspection on April 24, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- Person
- Ileana Barreto-Pettit (Issuing Officer)
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ID · eddc2e92-8a99-44b7-a9d2-1e829c95edac
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1087249
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Ansynth Service BV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 20, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ansynth Service BV
- FDA Inspection 886286 - 2014-06-20
- FDA Inspection 618247 - 2009-09-18
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