FDA Inspection 984596 — Island Kinetics, Inc. d.b.a. CoValence Laboratories
The FDA completed an inspection of Island Kinetics, Inc. d.b.a. CoValence Laboratories on September 2, 2016 in Chandler, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 2, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chandler, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |