FDA Inspection
Central Texas Community Health CentersCentral Texas Community Health Centers – FDA Inspection, Dec 9, 2009
Record Details
This FDA Inspection record concerns Central Texas Community Health Centers, with an inspection on December 9, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 9, 2009
- Product Type
- Drugs
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ID · d1a87b24-9fe5-42cc-835d-b6fc2af2ddb5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 632921
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.188(b)(9)Container/Closure Description
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.100(b)SOPs not followed / documented
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