FDA Inspection
Laboratorio Reig Jofre S.A.Laboratorio Reig Jofre S.A. – FDA Inspection, Jun 23, 2023
Record Details
This FDA Inspection record concerns Laboratorio Reig Jofre S.A., with an inspection on June 23, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3b386634-2baa-41f0-8775-5f68902cd68e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1208633
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Laboratorio Reig Jofre S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2019 | Not classified | Office of Inspections and Investigations | Generic Drug Evaluation |
| July 14, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 31, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratorio Reig Jofre S.A.
- FDA Inspection 1094577 - 2019-06-14
- FDA Inspection 937537 - 2015-07-14
- FDA Inspection 846291 - 2013-07-31
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