FDA Inspection
US Compounding IncUS Compounding Inc – FDA Inspection, Mar 27, 2014
Record Details
This FDA Inspection record concerns US Compounding Inc, with an inspection on March 27, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- US Compounding Inc
- Inspection Date
- March 27, 2014
- Product Type
- Drugs
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ID · 25f58193-d0f1-4d3f-81f0-37065d73bbf6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 874818
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.94(b)Protection from external factors
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.165(a)Testing and release for distribution
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Other FDA inspections of US Compounding Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 15, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 21, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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