FDA Inspection 1053508 — Cetylite Industries, Inc.
The FDA completed an inspection of Cetylite Industries, Inc. on May 29, 2018 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 29, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Pennsauken, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 10022 | 21 CFR 310.305(a) | Failure to develop written procedures |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 6706 | 21 CFR 310.305(c)(1)(i) | Late submission |