FDA Inspection 568902 — Morton Grove Pharmaceuticals, Inc.
The FDA completed an inspection of Morton Grove Pharmaceuticals, Inc. on March 17, 2009 in Morton Grove, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 17, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morton Grove, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |