FDA Inspection 1324124 — Gadal Laboratories Inc.
The FDA completed an inspection of Gadal Laboratories Inc. on Jun 29, 2026 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). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 29, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 18148 | 21 CFR 117.37 | Sanitary facilities and controls |
| 22829 | 21 CFR 111.20(c) | Physical plant - prevent mix-ups, contamination |
| 22837 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |