FDA Inspection 656460 — Sirio Nutrition (California) LLC
The FDA completed an inspection of Sirio Nutrition (California) LLC on April 2, 2010 in City Of Industry, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 2, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15473 | 21 CFR 111.20(c)(7) | Physical plant - separate areas - holding |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |