FDA Inspection 964585 — SSO, Inc. dba BYS Company
The FDA completed an inspection of SSO, Inc. dba BYS Company on March 18, 2016 in Lake Elsinore, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 18, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lake Elsinore, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |