FDA Inspection
Infinity Labs SD, IncInfinity Labs SD, Inc – FDA Inspection, Jun 3, 2026
Record Details
This FDA Inspection record concerns Infinity Labs SD, Inc, with an inspection on June 3, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · d063242e-1774-4d26-bc3a-686a7dd5b39a
Inspection Facts
- Inspection number
- 1320216
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
FDA Citations
2- ISO 13485:2016 Clause 7.6(a)Measuring equipment not adequately calibrated or verified
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Infinity Labs SD, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2023 | VAI | San Francisco District Office | |
| June 23, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Infinity Labs SD, Inc
- FDA Inspection 1215567 - 2023-08-21
- FDA Inspection 1145266 - 2021-06-23
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