FDA Inspection
Lucero Medical LLCLucero Medical LLC – FDA Inspection, Jun 8, 2012
Record Details
This FDA Inspection record concerns Lucero Medical LLC, with an inspection on June 8, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lucero Medical LLC
- Inspection Date
- June 8, 2012
- Product Type
- Devices
View Company Profile
ID · e10080bb-3df3-42a9-9a9b-2c8acec08efa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 788078
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.130Packaging
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.50(a)(2)Supplier oversight
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lucero Medical LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 22, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Lucero Medical LLC
- FDA Inspection 1178977 - 2022-09-07
- FDA Inspection 848609 - 2013-09-12
- FDA Inspection 754485 - 2011-11-22
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.