FDA Inspection
Medical Center Pharmacy, Inc.Medical Center Pharmacy, Inc. – FDA Inspection, Oct 13, 2015
Record Details
This FDA Inspection record concerns Medical Center Pharmacy, Inc., with an inspection on October 13, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 13, 2015
- Product Type
- Drugs
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ID · a34f51a2-0815-4bc9-83da-9dc0be385516
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 945314
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.113(a)Procedures for non-sterile drug products
Showing 10 of 14 citations.
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Other FDA inspections of Medical Center Pharmacy, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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