FDA Inspection
Abbott's Compounding Pharmacy, Inc.Abbott's Compounding Pharmacy, Inc. – FDA Inspection, Jan 8, 2016
Record Details
This FDA Inspection record concerns Abbott's Compounding Pharmacy, Inc., with an inspection on January 8, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 8, 2016
- Product Type
- Drugs
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ID · f753bfc5-3ded-4532-8942-844589f75ff0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 959102
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
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