FDA 483 - Cytophil, Inc. - July 29, 2022

Cytophil, Inc., a medical device manufacturer in East Troy, WI, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant issues primarily related to inadequate process validation, control of nonconforming products, sampling methods, and ineffective corrective and preventive actions. Several observations, particularly regarding validation and CAPA, were repeats from previous inspections and a Warning Letter, indicating persistent quality system deficiencies.