FDA Inspection
BioChem Labor fur biologische und chemische Analytik GMBHBioChem Labor fur biologische und chemische Analytik GMBH – FDA Inspection, Nov 7, 2017
Record Details
This FDA Inspection record concerns BioChem Labor fur biologische und chemische Analytik GMBH, with an inspection on November 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 7, 2017
- Product Type
- Drugs
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ID · 9185b2de-8574-4f96-8291-71c8d3ea31ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030971
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.160(a)Following/documenting laboratory controls
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Other FDA inspections of BioChem Labor fur biologische und chemische Analytik GMBH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 19, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 6, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for BioChem Labor fur biologische und chemische Analytik GMBH
- FDA Inspection 1203032 - 2022-03-23
- FDA Inspection 961140 - 2016-01-19
- FDA Inspection 839742 - 2013-06-06
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