FDA Inspection
Option Care Enterprises, Inc.Option Care Enterprises, Inc. – FDA Inspection, Jun 28, 2016
Record Details
This FDA Inspection record concerns Option Care Enterprises, Inc., with an inspection on June 28, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 28, 2016
- Product Type
- Drugs
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ID · 166cc5bd-1bc1-441f-9ac1-ea159dca1700
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 977462
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- State Referral Letter
FDA Citations
5- 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 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.113(b)Procedures for sterile drug products
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