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FDA Inspection
•Tools For Surgery, LLC•August 27, 2015

Tools For Surgery, LLC – FDA Inspection, Aug 27, 2015

Record Details

This FDA Inspection record concerns Tools For Surgery, LLC, with an inspection on August 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
Tools For Surgery, LLC
Inspection Date
August 27, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · f74793b2-7107-4489-843f-f2d37e439109

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
945562
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

2
  1. 21 CFR 820.40(a)Document review, approval by designated individual
  2. 21 CFR 820.72(a)Equipment control activity documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Tools For Surgery, LLC

4
DateClassificationOfficeProject area
November 6, 2025NAINew York District OfficePostmarket Assurance: Medical Devices
July 8, 2022NAICenter for Devices and Radiological HealthCompliance: Devices
November 26, 2018NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
December 10, 2012NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Tools For Surgery, LLC
  • FDA Inspection 1291166 - 2025-11-06
  • FDA Inspection 1175100 - 2022-07-08
  • FDA Inspection 1078130 - 2018-11-26
  • FDA Inspection 812801 - 2012-12-10

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