FDA Inspection
Aspira Women's Health, Inc.Aspira Women's Health, Inc. – FDA Inspection, Sep 24, 2026
Record Details
This FDA Inspection record concerns Aspira Women's Health, Inc., with an inspection on September 24, 2026, issued by the Dallas District Office, covering medical devices & rad health.
- Company
- Aspira Women's Health, Inc.
- Inspection Date
- September 24, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 38f0ce23-1b53-449c-96fc-dab9ab4eb515
Inspection Facts
- Inspection number
- 1337276
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.6Monitoring and measurement requirements not determined
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
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Other FDA inspections of Aspira Women's Health, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aspira Women's Health, Inc.
- FDA Inspection 967703 - 2016-03-31
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