FDA Inspection 905659 — Option Care
The FDA completed an inspection of Option Care on November 25, 2014 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 25, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |