FDA Inspection 1043914 — Resilience US, LLC
The FDA completed an inspection of Resilience US, LLC on Mar 8, 2018 in West Chester, OH. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 8, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Chester, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |