FDA Inspection 1097303 — S Bailey Enterprises, LLC
The FDA completed an inspection of S Bailey Enterprises, LLC on July 19, 2019 in Marks, MS. 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
- July 19, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Marks, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15388 | 21 CFR 111.10(b) | Personnel - hygienic practices |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15465 | 21 CFR 111.20(d)(2) | Air blowing equipment |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |