FDA Inspection
Oxarc IncOxarc Inc – FDA Inspection, Jun 24, 2011
Record Details
This FDA Inspection record concerns Oxarc Inc, with an inspection on June 24, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Oxarc Inc
- Inspection Date
- June 24, 2011
- Product Type
- Drugs
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ID · 741cb375-3697-4808-8189-ecff82a527b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 748440
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
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