FDA Inspection 1153103 — AIE Pharmacueticals, Inc.
The FDA completed an inspection of AIE Pharmacueticals, Inc. on September 17, 2021 in Ontario, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 17, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15898 | 21 CFR 111.83(b)(1) | Reserve sample -container-closure system |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |