FDA Inspection 651880 — Morton Grove Pharmaceuticals, Inc.
The FDA completed an inspection of Morton Grove Pharmaceuticals, Inc. on March 24, 2010 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morton Grove, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |