Company
United StatesK2M, Inc., Leesburg, VA – FDA Inspections
Inspection records and compliance data for K2M, Inc. in Leesburg, Virginia. 11 FDA inspections on record, 2 Form 483s, last inspected March 21, 2024.
Company Profile
This profile covers K2M, Inc. based in Leesburg, Virginia, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 0
- VAI
- 0
- NAI
- 10
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected January 18, 2011. Last inspected March 21, 2024.
Most cited issue areas
- Lack of or inadequate procedures - Acceptance activities1 inspection
- Records, DHR {see also 820.184(e)}1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 21, 2024 | NAI | Biologics · Blood and Blood Products | 1236122 |
| April 21, 2022 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1168720 |
| July 27, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1148726 |
| December 7, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1076835 |
| October 12, 2017 | Not classified | Medical Devices & Rad Health | 1078529 |
| November 16, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 992904 |
| April 21, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 967903 |
| July 6, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 933247 |
| February 12, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 866245 |
| March 21, 2012 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 774219 |
| January 18, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 706370 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
K2M, Inc.
FEI Number
3008599177
Address
600 Hope Pkwy Se, Leesburg, Virginia 20175, United States
Country
United States
ID: 03b0edf1-8ffe-422a-8877-c7bff00baa05