FDA Inspection
Innovative Compounding PharmacyInnovative Compounding Pharmacy – FDA Inspection, Apr 17, 2015
Record Details
This FDA Inspection record concerns Innovative Compounding Pharmacy, with an inspection on April 17, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 17, 2015
- Product Type
- Drugs
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ID · 2ae6828e-9448-46a3-a15f-a3c66cc4f433
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 922792
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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Other FDA inspections of Innovative Compounding Pharmacy
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Innovative Compounding Pharmacy
- FDA Inspection 1023925 - 2017-07-28
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