FDA Inspection 721355 — Cetylite Industries, Inc.
The FDA completed an inspection of Cetylite Industries, Inc. on Apr 26, 2011 in Pennsauken, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 26, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pennsauken, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |