FDA Inspection 1158969 — Ozona Organics LLC
The FDA completed an inspection of Ozona Organics LLC on December 16, 2021 in Ozona, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 16, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Ozona, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 18140 | 21 CFR 117.20(b) | Plant construction and design |
| 18157 | 21 CFR 117.80(b)(2) | Raw materials control - Microorganisms |
| 18210 | 21 CFR 507.22(a)(2) | Equipment and Utensils - avoid adulteration |
| 18223 | 21 CFR 507.25(c)(2) | Manufacturing, Processing, Packing, Holding - Measures |