FDA Inspection
ESI Inc.ESI Inc. – FDA Inspection, Mar 26, 2026
Record Details
This FDA Inspection record concerns ESI Inc., with an inspection on March 26, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.
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Inspection Facts
- Inspection number
- 1310166
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
11- ISO 13485:2016 Clause 4.2.3Medical device file does not contain specific requirements
- ISO 13485:2016 Clause 4.2.4Lack of document control
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.4.3Impact of changes to purchased product not determined
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
- ISO 13485:2016 Clause 8.3.1Nonconforming product not adequately evaluated
- ISO 13485:2016 Clause 6.1(a)Resources for quality management system have not been determined or provided
- ISO 13485:2016 Clause 6.2Process(es) for personnel competence, training and awareness not documented
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Other FDA inspections of ESI Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 11, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 6, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ESI Inc.
- FDA Inspection 1096338 - 2019-05-17
- FDA Inspection 938169 - 2015-08-11
- FDA Inspection 789659 - 2012-07-06
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