FDA Inspection
Gulf Coast Pharmaceutical Specialty dba GPS PharmacyGulf Coast Pharmaceutical Specialty dba GPS Pharmacy – FDA Inspection, Sep 21, 2011
Record Details
This FDA Inspection record concerns Gulf Coast Pharmaceutical Specialty dba GPS Pharmacy, with an inspection on September 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 21, 2011
- Product Type
- Drugs
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ID · 5619c209-e76a-47bc-b857-3f25ab16fa6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 746047
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.94(b)Protection from external factors
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
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