FDA Inspection 1268716 — Nulab, Inc.
The FDA completed an inspection of Nulab, Inc. on May 14, 2025 in Clearwater, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 14, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 22822 | 21 CFR 111.15(a) | Grounds - condition |
| 22837 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22863 | 21 CFR 111.110 | Quality control - Laboratory control processes; production, process control |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22892 | 21 CFR 111.303 | Written procedures - follow; laboratory |