FDA Inspection
Marson Medical, Inc.Marson Medical, Inc. – FDA Inspection, Jan 16, 2026
Record Details
This FDA Inspection record concerns Marson Medical, Inc., with an inspection on January 16, 2026, issued by the New Jersey District Office, covering medical devices & rad health.
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ID · ef148f5d-2b13-4634-b839-79d65b3f78dc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1301500
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
11- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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