FDA Inspection 1144121 — Ibitta Enterprises, Inc.
The FDA completed an inspection of Ibitta Enterprises, Inc. on June 4, 2021 in South Gate, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 4, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- South Gate, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |