FDA Inspection 1044033 — AIE Pharmacueticals, Inc.
The FDA completed an inspection of AIE Pharmacueticals, Inc. on March 12, 2018 in Ontario, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15433 | 21 CFR 111.15(d)(1) | Animals and pests in facility |
| 15478 | 21 CFR 111.20(f) | Physical plant - bulbs, fixtures, skylights |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |