FDA Inspection
Canton Laboratories LLCCanton Laboratories LLC – FDA Inspection, May 11, 2018
Record Details
This FDA Inspection record concerns Canton Laboratories LLC, with an inspection on May 11, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 78065acf-cdeb-4889-9c00-13cc84419429
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051973
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.204Record information inclusions
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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