FDA Inspection 948716 — Cetylite Industries, Inc.
The FDA completed an inspection of Cetylite Industries, Inc. on November 19, 2015 in Pennsauken, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pennsauken, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4576 | 21 CFR 211.192 | No written record of investigation |