FDA Inspection 707801 — Lex, Inc.
The FDA completed an inspection of Lex, Inc. on March 1, 2011 in Medley, FL. 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
- March 1, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Medley, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1207 | 21 CFR 211.65(b) | Substances That Come in Contact |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |