FDA Inspection 1278907 — Fareva Morton Grove, Inc.
The FDA completed an inspection of Fareva Morton Grove, Inc. on August 12, 2025 in Morton Grove, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 12, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morton Grove, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |