FDA Inspection 1031770 — Farmville Discount Drug, Inc. DBA Best Value Drug
The FDA completed an inspection of Farmville Discount Drug, Inc. DBA Best Value Drug on November 17, 2017 in Farmville, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 17, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farmville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 18941 | FDCA 501(a)(2)(A) | Improper gowning, contamination |
| 18949 | FDCA 501(a)(2)(A) | First pass air blockage, open unit with sterile product |
| 18951 | FDCA 501(a)(2)(A) | Personnel contact outside ISO 5 area |
| 18960 | FDCA 501(a)(2)(A) | Flow of personnel and materials, facility |
| 18961 | FDCA 501(a)(2)(A) | Air flow quality, higher classified area |
| 18964 | FDCA 501(a)(2)(A) | Unsealed HEPA filter, perimeter |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |