Company
United StatesLucero Medical LLC, Richfield, OH – FDA Inspections
Inspection records and compliance data for Lucero Medical LLC in Richfield, Ohio. 4 FDA inspections on record (1 OAI), last inspected September 07, 2022.
Company Profile
This profile covers Lucero Medical LLC based in Richfield, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected November 22, 2011. Last inspected September 7, 2022.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design control - no procedures1 inspection
- Design output - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 7, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1178977 |
| September 12, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 848609 |
| June 8, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 788078 |
| November 22, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 754485 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Lucero Medical LLC
FEI Number
3008775608
Address
4615 W Streetsboro Rd, Richfield, Ohio 44286, United States
Country
United States
ID: ddef43cd-2683-419a-b2db-804a15ea65d5