FDA Inspection 1177284 — ImprimisRx NJ LLC
The FDA completed an inspection of ImprimisRx NJ LLC on August 5, 2022 in Ledgewood, NJ. 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
- August 5, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ledgewood, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18942 | FDCA 501(a)(2)(A) | Personnel habits, contamination |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18957 | FDCA 501(a)(2)(A) | Dust-collecting overhangs, surrounding area of ISO 5 |
| 18961 | FDCA 501(a)(2)(A) | Air flow quality, higher classified area |
| 18972 | FDCA 501(a)(2)(A) | Inadequate sporicidal agents, cleanroom and ISO 5 area |
| 18973 | FDCA 501(a)(2)(A) | Disinfecting materials, aseptic processing area |