FDA Inspection
Charles River Laboratories, Inc.Charles River Laboratories, Inc. – FDA Inspection, Jun 15, 2018
Record Details
This FDA Inspection record concerns Charles River Laboratories, Inc., with an inspection on June 15, 2018, issued by the San Francisco District Office, covering human drugs.
- People
- Sandra S. Saniga (Issuing Officer)
- Zhou Chen (Company Rep)
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ID · 88515542-961a-4b71-8dba-863ac4022a8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055966
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 58.185(a)(9)Final report: circumstances affecting data qual., integrity
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Other FDA inspections of Charles River Laboratories, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2025 | VAI | San Francisco District Office | Bioresearch Monitoring: Human Drugs |
| May 26, 2017 | Not classified | San Francisco District Office | |
| January 13, 2017 | Not classified | San Francisco District Office |
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