FDA Inspection 944649 — Northwind Pharmaceuticals LLC
The FDA completed an inspection of Northwind Pharmaceuticals LLC on Sep 14, 2015 in Indianapolis, IN. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 14, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 4316 | 21 CFR 211.84(d)(3) | Testing Containers & Closures Conformity with Specs |
| 4371 | 21 CFR 211.188(b)(9) | Description of containers and closures |