FDA Inspection
Propack Contract Packaging IncPropack Contract Packaging Inc – FDA Inspection, Nov 18, 2009
Record Details
This FDA Inspection record concerns Propack Contract Packaging Inc, with an inspection on November 18, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 18, 2009
- Product Type
- Drugs
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ID · c1f4ef1f-7fde-4f34-aabc-e42f14fa4261
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 632059
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.82(a)Examination on receipt, before acceptance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.34Consultant Records
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