Company
United StatesHairmax International LLC, Boca Raton, FL – FDA Inspections
Inspection records and compliance data for Hairmax International LLC in Boca Raton, Florida. 5 FDA inspections on record, 2 Form 483s, last inspected June 14, 2018.
Company Profile
This profile covers Hairmax International LLC based in Boca Raton, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected February 3, 2009. Last inspected June 14, 2018.
Most cited issue areas
- Certification not based on adequate test/testing program1 inspection
- Investigation of device failures1 inspection
- Label locations1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 14, 2018 | Not classified | Medical Devices & Rad Health | 1071086 |
| February 2, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1040255 |
| March 21, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 773009 |
| February 25, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 648428 |
| February 3, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 567077 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hairmax International LLC
FEI Number
3006182775
Address
1040 Holland Dr, Boca Raton, Florida 33487, United States
Country
United States
ID: 99d95d73-2960-4d88-835a-891e6548b53a