FDA Inspection 1081078 — Northwestern Medicine Central DuPage Hospital
The FDA completed an inspection of Northwestern Medicine Central DuPage Hospital on Feb 22, 2019 in Winfield, IL. 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 22, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Winfield, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |