FDA Inspection
Laboratorio Reig Jofre S.A.Laboratorio Reig Jofre S.A. – FDA Inspection, Jun 14, 2019
Record Details
This FDA Inspection record concerns Laboratorio Reig Jofre S.A., with an inspection on June 14, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · a1bc4cd4-4839-4f92-8e25-09d6143d9c03
Inspection Facts
- Inspection number
- 1094577
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Laboratorio Reig Jofre S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1208633 - 2023-06-23
- FDA Inspection 937537 - 2015-07-14
- FDA Inspection 846291 - 2013-07-31
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