Company
United StatesEquilibrated Bio Systems, Smithtown, NY – FDA Inspections
Inspection records and compliance data for Equilibrated Bio Systems in Smithtown, New York. 5 FDA inspections on record, last inspected November 16, 2021.
Company Profile
This profile covers Equilibrated Bio Systems based in Smithtown, New York, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected March 2, 2010. Last inspected November 16, 2021.
Most cited issue areas
- Design control - no procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 16, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1157607 |
| October 2, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1068444 |
| July 23, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 935577 |
| January 14, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 813887 |
| March 2, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 649615 |
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
Equilibrated Bio Systems
FEI Number
3001236081
Address
22 Lawrence Ave Ste LL2, Smithtown, New York 11787, United States
Country
United States
ID: aeec8a16-5998-47b6-a5bb-8d740c153548