FDA Inspection 1316704 — Tecan CDMO Solutions MH, Corp
The FDA completed an inspection of Tecan CDMO Solutions MH, Corp on June 16, 2026 in Morgan Hill, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Morgan Hill, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23256 | ISO 13485:2016 Clause 8.5.2 | Corrective actions were unduly delayed |