FDA Inspection
Farmasierra Manufacturing, SLFarmasierra Manufacturing, SL – FDA Inspection, Jul 26, 2019
Record Details
This FDA Inspection record concerns Farmasierra Manufacturing, SL, with an inspection on July 26, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · ab84abd4-9b1a-487a-b97d-8a2c17125969
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097857
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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Other FDA inspections of Farmasierra Manufacturing, SL
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 30, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Farmasierra Manufacturing, SL
- FDA Inspection 1275513 - 2024-01-18
- FDA Inspection 1132083 - 2020-01-30
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