FDA 483 - Beverly Hills Uniforms - October 26, 2021

Beverly Hills Uniforms, a medical device manufacturer in Bronx, NY, was cited with a Form FDA-483 following an inspection. The inspection revealed significant deficiencies in the firm's quality system, including the absence of written procedures for Medical Device Reporting, complaint handling, and corrective and preventive actions. Additionally, the firm failed to ensure proper device traceability through control numbers, lot numbers, and Unique Device Identifiers.