FDA Inspection
Bionique Testing Laboratories LLCBionique Testing Laboratories LLC – FDA Inspection, Jul 26, 2012
Record Details
This FDA Inspection record concerns Bionique Testing Laboratories LLC, with an inspection on July 26, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 26, 2012
- Product Type
- Drugs
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ID · 5c8b4020-aaef-4893-a1a1-617e33f1367f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 795641
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)(4)Test devices not meeting specifications
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Bionique Testing Laboratories LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2026 | Not classified | New York District Office | |
| October 20, 2025 | Not classified | New York District Office | |
| September 4, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 22, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bionique Testing Laboratories LLC
- FDA Inspection 1300474 - 2026-01-15
- FDA Inspection 1290846 - 2025-10-20
- FDA Inspection 1129842 - 2020-09-04
- FDA Inspection 923594 - 2015-04-22
- FDA Inspection 645984 - 2010-02-03
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