FDA Inspection
Option CareOption Care – FDA Inspection, Aug 6, 2015
Record Details
This FDA Inspection record concerns Option Care, with an inspection on August 6, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Option Care
- Inspection Date
- August 6, 2015
- Product Type
- Drugs
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ID · 2ad31bdc-2e7e-402f-84b6-7ba4766562b1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 940486
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.166(a)Lack of written stability program
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Option Care
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2017 | Not classified | Dallas District Office |
Other documents for Option Care
- FDA Inspection 1023168 - 2017-07-21
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