FDA Inspection 1196762 — Sol-Ti, Inc.
The FDA completed an inspection of Sol-Ti, Inc. on Feb 8, 2023 in San Diego, CA. 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: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 8, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 12745 | 21 CFR 120.8(b)(1) | HACCP plan - food hazards not listed |
| 12749 | 21 CFR 120.8(b)(6) | HACCP plan - verify procedures / frequency - none listed |
| 15302 | 21 CFR 120.11(a)(2) | Calibration, testing - no records |
| 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 |
| 9939 | 21 CFR 120.7(c) | All hazards not considered |
| 9947 | 21 CFR 120.11(b) | HACCP plan - not validated |