FDA 483 - Wykle, Inc. - May 10, 2019

Wykle, Inc. in Carson City, NV, a manufacturer of Class 2 amalgam alloy, received an FDA Form 483 with eight observations during an inspection from May 6-10, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, equipment calibration, process validation, nonconforming product control, document control, quality audits, management review, and design change. These issues indicate a systemic lack of established and implemented quality management procedures.