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FDA Inspection
•Hairmax International LLC•February 25, 2010

Hairmax International LLC – FDA Inspection, Feb 25, 2010

Record Details

This FDA Inspection record concerns Hairmax International LLC, with an inspection on February 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company
Hairmax International LLC
Inspection Date
February 25, 2010
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · f5505477-93e8-480a-8d44-6c4e293deeb4

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
648428
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

2
  1. 21 CFR 1040.10(g)(9)Label locations
  2. 21 CFR 820.198(c)Investigation of device failures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Hairmax International LLC

4
DateClassificationOfficeProject area
June 14, 2018Not classifiedFlorida District Office
February 2, 2018VAICenter for Devices and Radiological HealthCompliance: Devices
March 21, 2012NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
February 3, 2009VAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for Hairmax International LLC
  • FDA Inspection 1071086 - 2018-06-14
  • FDA Inspection 1040255 - 2018-02-02
  • FDA Inspection 773009 - 2012-03-21
  • FDA Inspection 567077 - 2009-02-03

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