FDA Inspection
Crane Usa IncCrane Usa Inc – FDA Inspection, Apr 26, 2017
Record Details
This FDA Inspection record concerns Crane Usa Inc, with an inspection on April 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d6dfbf0f-0635-4b17-b002-28976f5b3f0c
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1013558
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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