FDA Inspection 702633 — Morton Grove Pharmaceuticals, Inc.
The FDA completed an inspection of Morton Grove Pharmaceuticals, Inc. on April 12, 2011 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morton Grove, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |