FDA Inspection
Eurofins BioPharma Product Testing Czech Republic s.r.o.Eurofins BioPharma Product Testing Czech Republic s.r.o. – FDA Inspection, Jul 29, 2014
Record Details
This FDA Inspection record concerns Eurofins BioPharma Product Testing Czech Republic s.r.o., with an inspection on July 29, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 29, 2014
- Product Type
- Drugs
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ID · cca7e136-ec3b-4624-bca0-a5e63ae6a4d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 892490
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Eurofins BioPharma Product Testing Czech Republic s.r.o.
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| July 24, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 16, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 20, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Eurofins BioPharma Product Testing Czech Republic s.r.o.
- FDA Inspection 1270980 - 2024-07-24
- FDA Inspection 1134811 - 2020-07-16
- FDA Inspection 988104 - 2016-08-09
- FDA Inspection 727383 - 2011-05-20
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