FDA Inspection
Biochem Laboratories, Inc.Biochem Laboratories, Inc. – FDA Inspection, May 14, 2012
Record Details
This FDA Inspection record concerns Biochem Laboratories, Inc., with an inspection on May 14, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Biochem Laboratories, Inc.
- Inspection Date
- May 14, 2012
- Product Type
- Drugs
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ID · fb90a146-7932-48f2-8822-97a2b7e097f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779784
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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Other FDA inspections of Biochem Laboratories, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2025 | VAI | New Jersey District Office | Drug Quality Assurance |
| 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 |
| 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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