KVK-TECH, INC. – FDA 483, Mar 13, 2020

An FDA inspection of KVK-Tech, Inc. in Newtown, PA, revealed significant deficiencies across multiple systems, including facility and equipment, packaging and labeling, laboratory controls, and quality systems. The firm failed to follow written procedures for equipment cleaning, maintain chronological logs, control access to limited areas, and adequately review electronic audit trails. Additionally, issues were noted with facility sanitation, incomplete batch records, deficient cleaning and sanitization schedules, and inadequate laboratory control mechanisms and analytical test procedures. The quality unit also failed to ensure proper change control, conduct internal audits, and qualify consultants, indicating systemic failures in GMP compliance.