FDA Inspection
Lone Star Medical Products, Inc.Lone Star Medical Products, Inc. – FDA Inspection, Apr 27, 2023
Record Details
This FDA Inspection record concerns Lone Star Medical Products, Inc., with an inspection on April 27, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ef747314-798b-435a-870b-83220631be99
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1203824
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lone Star Medical Products, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| August 6, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Lone Star Medical Products, Inc.
- FDA Inspection 1057460 - 2018-05-02
- FDA Inspection 1021325 - 2017-05-04
- FDA Inspection 896250 - 2014-09-23
- FDA Inspection 793298 - 2012-08-06
- FDA Inspection 711363 - 2011-02-24
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