FDA Inspection 1177681 — Bentley Laboratories LLC
The FDA completed an inspection of Bentley Laboratories LLC on August 17, 2022 in Edison, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |