FDA Inspection
Lucero Medical LLCLucero Medical LLC – FDA Inspection, Nov 22, 2011
Record Details
This FDA Inspection record concerns Lucero Medical LLC, with an inspection on November 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lucero Medical LLC
- Inspection Date
- November 22, 2011
- Product Type
- Devices
View Company Profile
ID · 8f69b9f4-b2e9-405b-a655-0797d2200f9b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 754485
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| June 8, 2012 | VAI | 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 788078 - 2012-06-08
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