FDA Inspection
Katalyst Surgical, LLCKatalyst Surgical, LLC – FDA Inspection, Jul 16, 2025
Record Details
This FDA Inspection record concerns Katalyst Surgical, LLC, with an inspection on July 16, 2025, issued by the Kansas City District Office, covering medical devices & rad health.
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ID · 57f987d9-7d7f-4e0f-aa67-025d9dce8793
Inspection Facts
- Inspection number
- 1275730
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(b)(3)Conducting an Investigation
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Katalyst Surgical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 15, 2016 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Katalyst Surgical, LLC
- FDA Inspection 1020942 - 2017-08-07
- FDA Inspection 966433 - 2016-03-15
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