FDA Inspection
Therapy SupportTherapy Support – FDA Inspection, Dec 13, 2012
Record Details
This FDA Inspection record concerns Therapy Support, with an inspection on December 13, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Therapy Support
- Inspection Date
- December 13, 2012
- Product Type
- Drugs
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ID · 037f13c1-2be5-4a28-a597-dbdc13f3ab78
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 813624
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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