FDA Inspection
Analytical Resource Laboratories LLCAnalytical Resource Laboratories LLC – FDA Inspection, Jul 20, 2018
Record Details
This FDA Inspection record concerns Analytical Resource Laboratories LLC, with an inspection on July 20, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 65246a88-7a11-47e3-8c31-7e5289f70669
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060583
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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