FDA Inspection
Austin Medical, Inc.Austin Medical, Inc. – FDA Inspection, Sep 18, 2026
Record Details
This FDA Inspection record concerns Austin Medical, Inc., with an inspection on September 18, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
- Company
- Austin Medical, Inc.
- Inspection Date
- September 18, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · cd6988be-9915-4802-bfe1-1d85572e5523
Inspection Facts
- Inspection number
- 1336258
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 4.2.5Records of conformity and QMS operations not maintained
- ISO 13485:2016 Clause 7.5.7Processes for sterilization and sterile barrier systems not validated
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Austin Medical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 10, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 26, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 22, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Austin Medical, Inc.
- FDA Inspection 1026448 - 2017-06-15
- FDA Inspection 858503 - 2013-12-10
- FDA Inspection 751930 - 2011-10-26
- FDA Inspection 613305 - 2009-07-22
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