FDA Inspection
Surgical Instrument Manufacturers, LLCSurgical Instrument Manufacturers, LLC – FDA Inspection, Oct 8, 2026
Record Details
This FDA Inspection record concerns Surgical Instrument Manufacturers, LLC, with an inspection on October 8, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 8, 2026
- Product Type
- Devices
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ID · 8622854a-dd82-43ec-a081-ae3b958372fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1340262
- Project area
- Compliance: Devices
FDA Citations
3- ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 4.1.3Risk-based approach not applied to QMS processes
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Other FDA inspections of Surgical Instrument Manufacturers, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 27, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 11, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 20, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Surgical Instrument Manufacturers, LLC
- FDA Inspection 1230704 - 2024-02-22
- FDA Inspection 1158788 - 2021-10-27
- FDA Inspection 1019539 - 2017-05-11
- FDA Inspection 863893 - 2014-01-15
- FDA Inspection 674762 - 2010-07-20
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