FDA Inspection 632085 — Armstrong Pharmaceuticals, Inc.
The FDA completed an inspection of Armstrong Pharmaceuticals, Inc. on Nov 13, 2009 in Canton, MA. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 13, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Canton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |