FDA Inspection
Lone Star Medical Products, Inc.Lone Star Medical Products, Inc. – FDA Inspection, Aug 6, 2012
Record Details
This FDA Inspection record concerns Lone Star Medical Products, Inc., with an inspection on August 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 6, 2012
- Product Type
- Devices
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ID · bb80d316-cdf9-46c8-a29e-c1e7f29859d8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 793298
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(f)Records accessibility
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 806.20(a)Records not kept
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Other FDA inspections of Lone Star Medical Products, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 2, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 4, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 23, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 24, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Lone Star Medical Products, Inc.
- FDA Inspection 1203824 - 2023-04-27
- FDA Inspection 1057460 - 2018-05-02
- FDA Inspection 1021325 - 2017-05-04
- FDA Inspection 896250 - 2014-09-23
- FDA Inspection 711363 - 2011-02-24
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