FDA Inspection
Surgical Instrument Manufacturers, LLCSurgical Instrument Manufacturers, LLC – FDA Inspection, Jul 20, 2010
Record Details
This FDA Inspection record concerns Surgical Instrument Manufacturers, LLC, with an inspection on July 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 20, 2010
- Product Type
- Devices
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ID · b247faae-ce2c-4af8-8fbc-debefe86d235
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 674762
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(b)Training records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Surgical Instrument Manufacturers, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 8, 2026 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for Surgical Instrument Manufacturers, LLC
- FDA Inspection 1340262 - 2026-10-08
- FDA Inspection 1230704 - 2024-02-22
- FDA Inspection 1158788 - 2021-10-27
- FDA Inspection 1019539 - 2017-05-11
- FDA Inspection 863893 - 2014-01-15
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