FDA Inspection 1098887 — Randol Mill Pharmacy
The FDA completed an inspection of Randol Mill Pharmacy on Aug 6, 2019 in Arlington, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 6, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Arlington, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 18944 | FDCA 501(a)(2)(A) | Exposure of personnel in aspectic processing |
| 18961 | FDCA 501(a)(2)(A) | Air flow quality, higher classified area |
| 18966 | FDCA 501(a)(2)(A) | Non-sterilized and non-depyrogenated, sterile drug |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |