FDA Inspection 976566 — Vita Pharmacy, LLC
The FDA completed an inspection of Vita Pharmacy, LLC on Jun 29, 2016 in San Antonio, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 29, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |