FDA Inspection 737870 — Xymogen Manufacturing
The FDA completed an inspection of Xymogen Manufacturing on August 1, 2011 in Orlando, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 1, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16000 | 21 CFR 111.130 | Quality control operations - returned dietary supplement |
| 16007 | 21 CFR 111.135 | Quality control operations - product complaints |