FDA Inspection 775438 — Montgomery County Chapter Nysarc, Inc.
The FDA completed an inspection of Montgomery County Chapter Nysarc, Inc. on Apr 5, 2012 in Amsterdam, NY. 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
- Apr 5, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amsterdam, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4316 | 21 CFR 211.84(d)(3) | Testing Containers & Closures Conformity with Specs |