FDA Inspection
Sua Inc.Sua Inc. – FDA Inspection, Jun 9, 2015
Record Details
This FDA Inspection record concerns Sua Inc., with an inspection on June 9, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sua Inc.
- Inspection Date
- June 9, 2015
- Product Type
- Drugs
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ID · d3b2aec1-ec9c-49fe-8615-513e20ccdf87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 934012
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.192No written record of investigation
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