FDA Inspection 1257783 — CTK OTC Laboratories LLC
The FDA completed an inspection of CTK OTC Laboratories LLC on December 31, 2024 in Corona, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 31, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Corona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |
| 4576 | 21 CFR 211.192 | No written record of investigation |