FDA Inspection
Nutek Bravo LLCNutek Bravo LLC – FDA Inspection, Sep 17, 2026
Record Details
This FDA Inspection record concerns Nutek Bravo LLC, with an inspection on September 17, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · b55f2db3-fcf5-4ac1-9f74-2f03477be05b
Inspection Facts
- Inspection number
- 1338386
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Nutek Bravo LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 30, 2025 | Not classified | San Francisco District Office | |
| July 22, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for Nutek Bravo LLC
- FDA Inspection 1334004 - 2026-08-25
- FDA Inspection 1290462 - 2025-10-30
- FDA Inspection 1147798 - 2021-07-22
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