MAST GROUP LTD – FDA Inspection, Mar 26, 2026

Record Details

This FDA Inspection record concerns MAST GROUP LTD, with an inspection on March 26, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: MAST GROUP LTD
Inspection Date: March 26, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Jesse A. Vazquez (FDA Associated Person)

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ID · cd1fa15c-0383-464b-bdb7-38054c2ff110

Inspection Facts

Inspection number: 1313752
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.17Lack of Written MDR Procedures
ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented

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FDA Inspection

MAST GROUP LTDMarch 26, 2026