FDA Inspection
Central Admixture Pharmacy Services, Inc.Central Admixture Pharmacy Services, Inc. – FDA Inspection, Feb 20, 2014
Record Details
This FDA Inspection record concerns Central Admixture Pharmacy Services, Inc., with an inspection on February 20, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 20, 2014
- Product Type
- Drugs
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ID · 0fff3104-ca9b-488a-9779-a87a58da5a54
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 869831
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.42(d)Penicillin processing area not kept separate
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.150Written distribution procedure
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