GYMMAX TECHNOLOGY SHENZHEN CO., LTD., Shenzhen, China – FDA Inspections

Inspection records and compliance data for GYMMAX TECHNOLOGY SHENZHEN CO., LTD. in Shenzhen. 2 FDA inspections on record, 1 Form 483, last inspected June 15, 2017.

Company Profile

This profile covers GYMMAX TECHNOLOGY SHENZHEN CO., LTD. based in Shenzhen, China.

FDA Inspection History

FDA inspections: 2
OAI: 0
VAI: 1
NAI: 0
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected October 23, 2014. Last inspected June 15, 2017.

Most cited issue areas

Design changes - Lack of or Inadequate Procedures1 inspection
Design validation - user needs and intended uses1 inspection
Design verification - output does not meet input requirement1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
June 15, 2017	Not classified	Medical Devices & Rad Health · Compliance: Devices	1016646
October 23, 2014	VAI	Medical Devices & Rad Health · Compliance: Devices	902866

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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