FDA 483 - Wexler Surgical, Inc. - November 02, 2022

Wexler Surgical, Inc. in Houston, TX, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant issues with the firm's quality system, including inadequate documentation of corrective and preventive actions, poorly maintained device master records, and insufficient control of nonconforming products. Several observations were repeats from previous inspections, indicating persistent quality system deficiencies.