FDA Inspection
Charles River Endotoxin Microbial Detection EuropeCharles River Endotoxin Microbial Detection Europe – FDA Inspection, Apr 25, 2019
Record Details
This FDA Inspection record concerns Charles River Endotoxin Microbial Detection Europe, with an inspection on April 25, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- April 25, 2019
- Product Type
- Human Drugs
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ID · d3020efb-dc54-430d-bed8-72212cf41601
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087366
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Charles River Endotoxin Microbial Detection Europe
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 31, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Charles River Endotoxin Microbial Detection Europe
- FDA Inspection 1247243 - 2024-06-05
- FDA Inspection 875413 - 2014-03-31
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