FDA Inspection 1049813 — Coupler LLC
The FDA completed an inspection of Coupler LLC on April 27, 2018 in West Chester, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 27, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Chester, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |