FDA Inspection 1175965 — OHM Pharma, Inc.
The FDA completed an inspection of OHM Pharma, Inc. on Jul 29, 2022 in Mineral Wells, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 29, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Mineral Wells, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |