FDA Inspection 1152257 — W.S. Badger Company, Inc.
The FDA completed an inspection of W.S. Badger Company, Inc. on Sep 14, 2021 in Gilsum, NH. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 14, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gilsum, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |