FDA Inspection 1241346 — Arzol Chemical Company
The FDA completed an inspection of Arzol Chemical Company on Jun 14, 2024 in Keene, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Keene, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |