FDA Inspection 1087512 — Optimum Bioenergy International Corp.
The FDA completed an inspection of Optimum Bioenergy International Corp. on April 26, 2019 in Corona, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Corona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |