FDA Inspection 1308780 — Coupler LLC
The FDA completed an inspection of Coupler LLC on March 2, 2026 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 2, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Chester, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |