FDA Inspection 940486 — Option Care
The FDA completed an inspection of Option Care on August 6, 2015 in San Antonio, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 6, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |