FDA Inspection
Ablexan CorporationAblexan Corporation – FDA Inspection, Nov 7, 2016
Record Details
This FDA Inspection record concerns Ablexan Corporation, with an inspection on November 7, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5fe797fd-b561-426c-bd07-d3e8258363b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993193
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of Ablexan Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 29, 2025 | Not classified | Atlanta District Office | |
| January 23, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 14, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 20, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ablexan Corporation
- FDA Inspection 1290038 - 2025-10-29
- FDA Inspection 1195681 - 2023-01-23
- FDA Inspection 863103 - 2014-01-14
- FDA Inspection 737046 - 2011-07-20
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