FDA Inspection 635738 — Montgomery County Chapter Nysarc, Inc.
The FDA completed an inspection of Montgomery County Chapter Nysarc, Inc. on December 15, 2009 in Amsterdam, NY. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 15, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amsterdam, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |