FDA Inspection
Sol-ti, Inc.Sol-ti, Inc. – FDA Inspection, Feb 8, 2023
Record Details
This FDA Inspection record concerns Sol-ti, Inc., with an inspection on February 8, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Mary C. Wall (Issuing Officer)
- Sparky L. Bartee
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ID · db99d956-4860-4398-9fcf-96743dab047f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1196762
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
26- 21 CFR 120.7(c)All hazards not considered
- 21 CFR 120.6(b)Sanitation monitoring
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 120.8(a)HACCP plan not implemented
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 120.11(b)HACCP plan - not validated
- 21 CFR 120.11(a)(2)Calibration, testing - no records
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Other FDA inspections of Sol-ti, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2026 | Not classified | Los Angeles District Office | Foodborne Biological Hazards |
| September 12, 2024 | Not classified | Los Angeles District Office | |
| October 5, 2023 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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