FDA Inspection 876229 — Oza Compound Products, LLC
The FDA completed an inspection of Oza Compound Products, LLC on April 24, 2014 in Fort Wayne, IN. 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
- April 24, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fort Wayne, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15478 | 21 CFR 111.20(f) | Physical plant - bulbs, fixtures, skylights |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15512 | 21 CFR 111.27(d)(1) | Equipment - taken apart |
| 15516 | 21 CFR 111.27(d)(3) | Contact surfaces - consecutive operation - cleaning |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15920 | 21 CFR 111.95(b)(1) | Records - established specifications |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |