FDA Inspection
Charles River Laboratories, LLCCharles River Laboratories, LLC – FDA Inspection, Mar 8, 2018
Record Details
This FDA Inspection record concerns Charles River Laboratories, LLC, with an inspection on March 8, 2018, issued by the Chicago District Office, covering human drugs.
- Office
- Chicago District Office
- Person
- Shalonda C. Clifford (Issuing Officer)
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ID · b8c93b6f-7abd-4921-8b0d-2bcc5672c107
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043554
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 58.35(b)(1)QAU: maintain a master schedule
- 21 CFR 58.35(b)(5)QAU: authorize deviations from protocols or SOPs
- 21 CFR 58.35(b)(7)QAU: signed statement in final report
- 21 CFR 58.51Facility: archives
- 21 CFR 58.63(a)Equipment: inspection, cleaning and maintenance
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Other FDA inspections of Charles River Laboratories, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 20, 2024 | Not classified | Chicago District Office | |
| July 26, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 14, 2018 | Not classified | Chicago District Office | |
| July 21, 2017 | Not classified | Chicago District Office |
Other documents for Charles River Laboratories, LLC
- FDA Inspection 1263866 - 2025-02-14
- FDA Inspection 1251094 - 2024-09-20
- FDA Inspection 1097850 - 2019-07-26
- FDA Inspection 1072430 - 2018-09-14
- FDA Inspection 1025855 - 2017-07-21
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