Company
United StatesSMK Imaging LLC, Elmsford, NY – FDA Inspections
Inspection records and compliance data for SMK Imaging LLC in Elmsford, New York. 6 FDA inspections on record, last inspected March 28, 2022.
Company Profile
This profile covers SMK Imaging LLC based in Elmsford, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected April 15, 2010. Last inspected March 28, 2022.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design output - review and approval1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 28, 2022 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1166300 |
| October 23, 2019 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1108788 |
| August 16, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1022746 |
| August 7, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 940586 |
| April 29, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 830365 |
| April 15, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 657556 |
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
SMK Imaging LLC
FEI Number
3010609444
Address
8 Westchester Plz Ste 112 Ste 240, Elmsford, New York 10523, United States
Country
United States
ID: 46f2f1e4-4848-4d6a-a7ff-285f583d1a00