FDA Inspection 765870 — El-Gen LLC
The FDA completed an inspection of El-Gen LLC on January 31, 2012 in Bohemia, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 31, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Bohemia, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15739 | 21 CFR 111.210(h)(3)(ii)(B) | Components; add, verify |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |