FDA Inspection 599328 — Arzol Chemical Company
The FDA completed an inspection of Arzol Chemical Company on Jul 14, 2009 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 14, 2009
- Fiscal Year
- 2009
- 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 |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2001 | 21 CFR 211.184(b) | Component Test Records |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |