FDA Inspection 621269 — Armstrong Pharmaceuticals, Inc.
The FDA completed an inspection of Armstrong Pharmaceuticals, Inc. on September 29, 2009 in Canton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Canton, MA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6823 | 21 CFR 314.80(c) | Failure by applicant to report ADE |
| 6830 | 21 CFR 314.80(c)(2) | Interval |
| 8906 | 21 CFR 314.81(b)(1)(i) | Mix-up |
| 8908 | 21 CFR 314.81(b)(2)(i) | Summary |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |