FDA Inspection
Charles River Laboratories, Inc.Charles River Laboratories, Inc. – FDA Inspection, Dec 6, 2016
Record Details
This FDA Inspection record concerns Charles River Laboratories, Inc., with an inspection on December 6, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 61761b81-26f5-431b-899a-1af029078f95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 999079
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.194(b)Test method modification records do not include
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Charles River Laboratories, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 16, 2023 | Not classified | New England District Office | |
| November 9, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 1, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Charles River Laboratories, Inc.
- FDA Inspection 1284252 - 2025-09-17
- FDA Inspection 1217007 - 2023-08-16
- FDA Inspection 1072800 - 2018-11-09
- FDA Inspection 699489 - 2010-12-01
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