FDA Inspection 1046210 — Ridge Properties, LLC
The FDA completed an inspection of Ridge Properties, LLC on Mar 30, 2018 in Salem, OR. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 30, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salem, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4322 | 21 CFR 211.101(d) | Component release checked by 2nd person |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |