FDA Inspection
ECLOSIONECLOSION – FDA Inspection, Aug 13, 2026
Record Details
This FDA Inspection record concerns ECLOSION, with an inspection on August 13, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ed1d9ead-5e39-4180-aa01-a0fcfe697dec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1330786
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
14- ISO 13485:2016 Clause 4.2.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 4.2.4Lack of document control
- ISO 13485:2016 Clause 8.3.3Records not maintained for nonconforming product actions detected after delivery
- ISO 13485:2016 Clause 7.3.10Design and development files not maintained
- 21 CFR 830Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 7.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 7.1Processes needed for product realization not planned and developed
- 21 CFR 803Lack of Written MDR Procedures
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 8.5.3Preventive action procedures not documented
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