FDA Inspection
Surgical Instrument Manufacturers, LLCSurgical Instrument Manufacturers, LLC – FDA Inspection, Jan 15, 2014
Record Details
This FDA Inspection record concerns Surgical Instrument Manufacturers, LLC, with an inspection on January 15, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 15, 2014
- Product Type
- Devices
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ID · f52bd4b2-dd8b-44ce-8adf-f0267b6593a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 863893
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.22Quality Audits - defined intervals
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 |
| July 20, 2010 | 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 674762 - 2010-07-20
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