FDA Inspection 1181276 — Sure-Biochem Laboratories, LLC
The FDA completed an inspection of Sure-Biochem Laboratories, LLC on October 7, 2022 in Camden, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 7, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Camden, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1420 | 21 CFR 211.42(c)(9) | Control / Lab Operations Area |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |