Company
United StatesK2 Health Products LLC, Brooklyn, NY – FDA Inspections
Inspection records and compliance data for K2 Health Products LLC in Brooklyn, New York. 3 FDA inspections on record, last inspected November 15, 2022.
Company Profile
This profile covers K2 Health Products LLC based in Brooklyn, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected May 10, 2012. Last inspected November 15, 2022.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 15, 2022 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1190598 |
| February 3, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 970183 |
| May 10, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 785086 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
K2 Health Products LLC
FEI Number
3007220726
Address
5377 Kings Hwy, Brooklyn, New York 11203, United States
Country
United States
ID: 93d24e17-0d0c-45eb-b283-063cee465990