FDA Inspection
BioChroma Analytical Labs, LLC.BioChroma Analytical Labs, LLC. – FDA Inspection, Feb 8, 2017
Record Details
This FDA Inspection record concerns BioChroma Analytical Labs, LLC., with an inspection on February 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Anh Lac (Issuing Officer)
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ID · 66f8a2f4-6e84-4957-8464-7942d34a8311
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009808
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of BioChroma Analytical Labs, LLC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2026 | Not classified | Dallas District Office |
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