FDA Inspection 1229737 — SCARLETH RESEARCH LLC
The FDA completed an inspection of SCARLETH RESEARCH LLC on Apr 22, 2025 in Cutler Bay, 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). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 22, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Cutler Bay, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 16084 | 21 CFR 111.140(b)(3) | Records - material review, follow-up |
| 22840 | 21 CFR 111.35(b) | Make and keep records - equipment and utensils |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22907 | 21 CFR 111.475(b) | Records - written procedures holding and distribution; product distribution |
| 22911 | 21 CFR 111.535(b) | Make and keep records - returned dietary supplements |
| 22915 | 21 CFR 111.570(b) | Records - written procedures; product complaint |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |