FDA Inspection
Astura MedicalAstura Medical – FDA Inspection, Apr 23, 2026
Record Details
This FDA Inspection record concerns Astura Medical, with an inspection on April 23, 2026, issued by the Dallas District Office, covering medical devices & rad health.
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ID · d0973835-9543-4d16-9d15-ae0b2d5be028
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1313620
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 7.4.1Supplier performance not monitored
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
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Other FDA inspections of Astura Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2018 | Not classified | Dallas District Office |
Other documents for Astura Medical
- FDA Inspection 1082156 - 2018-11-19
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