FDA Inspection 1214374 — Coupler LLC
The FDA completed an inspection of Coupler LLC on August 10, 2023 in West Chester, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 10, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Chester, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 3597 | 21 CFR 211.122(g)(3) | Visual inspection |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |