FDA Inspection
Laboratorio Reig Jofre, S.A.Laboratorio Reig Jofre, S.A. – FDA Inspection, Jul 24, 2015
Record Details
This FDA Inspection record concerns Laboratorio Reig Jofre, S.A., with an inspection on July 24, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Laboratorio Reig Jofre, S.A.
- Inspection Date
- July 24, 2015
- Product Type
- Drugs
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ID · 1bbb84b0-18f7-418d-8d0a-da976d1772a7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 939459
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.58Buildings not maintained in good state of repair
- 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 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 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.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2019 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
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