FDA Inspection 1219750 — Sol-ti, Inc.
The FDA completed an inspection of Sol-ti, Inc. on October 5, 2023 in San Diego, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 5, 2023
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 22717 | 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9947 | 21 CFR 120.11(b) | HACCP plan - not validated |