FDA Inspection 958730 — Arzol Chemical Company
The FDA completed an inspection of Arzol Chemical Company on Jan 25, 2016 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 25, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Keene, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1726 | 21 CFR 211.86 | Rotation of components/containers/closures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |