FDA Inspection
Laboratorios Farmalan, S.A.Laboratorios Farmalan, S.A. – FDA Inspection, Nov 14, 2023
Record Details
This FDA Inspection record concerns Laboratorios Farmalan, S.A., with an inspection on November 14, 2023, issued by the Office of Inspections and Investigations.
- Company
- Laboratorios Farmalan, S.A.
- Inspection Date
- November 14, 2023
View Company Profile
ID · d6b9fe23-00c5-43a2-b066-72ce7075cbdb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222655
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.194(a)(5)Calculations performed are in the records
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Other FDA inspections of Laboratorios Farmalan, S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 19, 2019 | Not classified | Office of Inspections and Investigations | Generic Drug Evaluation |
Other documents for Laboratorios Farmalan, S.A.
- FDA Inspection 1210811 - 2021-11-17
- FDA Inspection 1083518 - 2019-03-19
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