FDA Inspection
Access Point Technologies EP, Inc.Access Point Technologies EP, Inc. – FDA Inspection, May 1, 2026
Record Details
This FDA Inspection record concerns Access Point Technologies EP, Inc., with an inspection on May 1, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.
- Inspection Date
- May 1, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 54757991-1545-45fb-a1a6-26716136211d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1315018
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented
- ISO 13485:2016 Clause 7.5.7Sterilization and sterile barrier system validation procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Access Point Technologies EP, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 23, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 16, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 4, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Access Point Technologies EP, Inc.
- FDA Inspection 1194801 - 2022-12-20
- FDA Inspection 1001757 - 2017-02-23
- FDA Inspection 845090 - 2013-07-16
- FDA Inspection 648455 - 2010-03-04
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