FDA Inspection
Charles River Laboratories Germany GmbHCharles River Laboratories Germany GmbH – FDA Inspection, Dec 15, 2017
Record Details
This FDA Inspection record concerns Charles River Laboratories Germany GmbH, with an inspection on December 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e0e5b6d7-24ab-451c-977f-eef4b0048bee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035009
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Charles River Laboratories Germany GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 4, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 23, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Charles River Laboratories Germany GmbH
- FDA Inspection 1203339 - 2021-08-24
- FDA Inspection 920651 - 2015-03-04
- FDA Inspection 748103 - 2011-09-23
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