FDA 483 - The Richline Group Inc - April 16, 2025

The Richline Group Inc. received an FDA Form 483 with 17 observations, many of which are repeat deficiencies from a previous inspection. The observations primarily concern the manufacturing and distribution of Inverness Home Ear Piercing Kits, Ear Care Solution, and Ear Care Antiseptic. Key issues include a lack of established design controls, inadequate process validation, poor water system qualification, insufficient control of nonconforming products, and deficiencies in complaint handling, CAPA, software validation, equipment calibration, incoming inspection, sampling methods, device master records, device history records, training, product identification, UDI implementation, GUDID submission, and supplier assessment.