FDA Inspection
Gentuity, LLCGentuity, LLC – FDA Inspection, Mar 5, 2026
Record Details
This FDA Inspection record concerns Gentuity, LLC, with an inspection on March 5, 2026, issued by the New England District Office, covering medical devices & rad health.
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ID · 4227b8c2-24cf-4f64-b5e3-6552554b8f5c
Inspection Facts
- Inspection number
- 1307694
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
- ISO 13485:2016 Clause 7.4.1Supplier evaluation and selection criteria do not include required elements
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities are inadequate
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Gentuity, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2022 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Gentuity, LLC
- FDA Inspection 1180446 - 2022-09-16
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