FDA Inspection 952157 — Northwind Pharmaceuticals LLC
The FDA completed an inspection of Northwind Pharmaceuticals LLC on December 9, 2015 in Indianapolis, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 9, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |