FDA Inspection
Hairmax International LLCHairmax International LLC – FDA Inspection, Feb 2, 2018
Record Details
This FDA Inspection record concerns Hairmax International LLC, with an inspection on February 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 46183d8d-c5b5-44c4-abb8-de7c1c8ebf10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040255
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hairmax International LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2018 | Not classified | Florida District Office | |
| March 21, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 25, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Hairmax International LLC
- FDA Inspection 1071086 - 2018-06-14
- FDA Inspection 773009 - 2012-03-21
- FDA Inspection 648428 - 2010-02-25
- FDA Inspection 567077 - 2009-02-03
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