FDA Inspection 1271683 — Kappa Laboratories, Inc.
The FDA completed an inspection of Kappa Laboratories, Inc. on Jun 4, 2025 in Miami, FL. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 4, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4576 | 21 CFR 211.192 | No written record of investigation |