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FDA Inspection
•Linemaster Switch Corporation•February 15, 2023

Linemaster Switch Corporation – FDA Inspection, Feb 15, 2023

Record Details

This FDA Inspection record concerns Linemaster Switch Corporation, with an inspection on February 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company
Linemaster Switch Corporation
Inspection Date
February 15, 2023
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Jeffrey J. Thibodeau (FDA Associated Person)
View Company Profile

ID · cbd34339-8d85-4a7a-96d1-97f55033cc64

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1199731
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 820.184DHR content
  2. 21 CFR 820.72(a)Equipment suitability & capability
  3. 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Linemaster Switch Corporation

4
DateClassificationOfficeProject area
March 6, 2026OAINew England District OfficeCompliance: Devices
April 12, 2018NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
October 1, 2014VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
January 12, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Linemaster Switch Corporation
  • FDA Inspection 1306502 - 2026-03-06
  • FDA Inspection 1051163 - 2018-04-12
  • FDA Inspection 899750 - 2014-10-01
  • FDA Inspection 768698 - 2012-01-12

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