FDA Inspection
Faes Farma, S.A.Faes Farma, S.A. – FDA Inspection, May 10, 2019
Record Details
This FDA Inspection record concerns Faes Farma, S.A., with an inspection on May 10, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Angela E. Glenn (Issuing Officer)
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ID · 3a7cadfd-ab01-47bd-9ad0-05b64d2fd808
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089311
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
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Other FDA inspections of Faes Farma, S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2016 | Not classified | Office of Inspections and Investigations |
Other documents for Faes Farma, S.A.
- FDA Inspection 1264912 - 2024-02-23
- FDA Inspection 993114 - 2016-10-21
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