FDA Inspection 988291 — Sage Products, LLC
The FDA completed an inspection of Sage Products, LLC on Sep 1, 2016 in Cary, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 1, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cary, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |