FDA Inspection 1097616 — Arcman Pharma Corporation
The FDA completed an inspection of Arcman Pharma Corporation on July 26, 2019 in Ontario, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |