FDA Inspection
Cape Medical Supply, Inc.Cape Medical Supply, Inc. – FDA Inspection, May 11, 2012
Record Details
This FDA Inspection record concerns Cape Medical Supply, Inc., with an inspection on May 11, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cape Medical Supply, Inc.
- Inspection Date
- May 11, 2012
- Product Type
- Drugs
View Company Profile
ID · 0baf75c3-91b1-4329-9063-f9dffb36c0fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780839
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.192Investigations of discrepancies, failures
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