FDA Inspection 1114441 — Island Kinetics, Inc. D.B.A. CoValence Laboratories
The FDA completed an inspection of Island Kinetics, Inc. D.B.A. CoValence Laboratories on Jan 6, 2020 in Chandler, AZ. 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). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 6, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chandler, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |