483
Beverly Hills UniformsBeverly Hills Uniforms – FDA 483, Oct 26, 2021
Record Details
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.
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ID · 316c1f18-8e9c-4d13-8b71-8660d8f108b8
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