FDA Inspection 1320974 — Cordica Medical (formerly Team Technologies Molding)
The FDA completed an inspection of Cordica Medical (formerly Team Technologies Molding) on June 8, 2026 in Batavia, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Batavia, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23033 | ISO 13485:2016 Clause 4.2.1 | QMS documentation does not include required documents |
| 23075 | ISO 13485:2016 Clause 6.2(e) | Records of personnel competence not maintained |
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |