FDA Inspection
Southeastern Technology Inc. dba Autocam MedicalSoutheastern Technology Inc. dba Autocam Medical – FDA Inspection, Apr 7, 2017
Record Details
This FDA Inspection record concerns Southeastern Technology Inc. dba Autocam Medical, with an inspection on April 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 7, 2017
- Product Type
- Devices
- Person
- Bonnie E. Conley (Issuing Officer)
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ID · a6e34f5e-1bd2-471a-832f-8d6397ff05b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007448
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Southeastern Technology Inc. dba Autocam Medical
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 4, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 22, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Southeastern Technology Inc. dba Autocam Medical
- FDA Inspection 1222746 - 2023-11-09
- FDA Inspection 1123232 - 2020-03-04
- FDA Inspection 716913 - 2011-03-22
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