FDA Inspection
Laboratorios Farmalan, S.A.Laboratorios Farmalan, S.A. – FDA Inspection, Mar 19, 2019
Record Details
This FDA Inspection record concerns Laboratorios Farmalan, S.A., with an inspection on March 19, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 83eb13c7-5333-47be-b15a-b75a92262df4
Inspection Facts
- Inspection number
- 1083518
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.46(b)Equipment for Environmental Control
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Other FDA inspections of Laboratorios Farmalan, S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2023 | VAI | Office of Inspections and Investigations | |
| November 17, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratorios Farmalan, S.A.
- FDA Inspection 1222655 - 2023-11-14
- FDA Inspection 1210811 - 2021-11-17
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