FDA Inspection 1252514 — Meta Labs Pharmaceuticals, LLC
The FDA completed an inspection of Meta Labs Pharmaceuticals, LLC on October 24, 2024 in Roswell, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 24, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Roswell, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 16002 | 21 CFR 111.130(a)(1) | QC operations - returned dietary supplement; tests, examinations necessary |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22886 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications, quality; packaging, labeling |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |