FDA Inspection 1328694 — Infinite Biomedical Technologies
The FDA completed an inspection of Infinite Biomedical Technologies on Jul 30, 2026 in Baltimore, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 30, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23068 | ISO 13485:2016 Clause 6.1(b) | Resources for meeting regulatory and customer requirements not provided |
| 23104 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs do not include all requirements |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |