FDA Inspection
Biochem Laboratories, Inc.Biochem Laboratories, Inc. – FDA Inspection, Jul 24, 2025
Record Details
This FDA Inspection record concerns Biochem Laboratories, Inc., with an inspection on July 24, 2025, issued by the New Jersey District Office, covering human drugs.
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ID · 43a287f5-6104-46d6-8f43-d4a884030e12
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1276819
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Biochem Laboratories, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 10, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 14, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 9, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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