FDA 483 - Sterling Knight Pharmaceuticals, LLC - April 11, 2019

An FDA inspection of Sterling Knight Pharmaceuticals, LLC in Ripley, MS, an own-label distributor of human drug products, revealed significant deficiencies in its quality system. The firm lacks a functional quality control unit responsible for critical tasks like complaint investigations, procedure approval, and contract manufacturer qualification. Additionally, the company failed to follow its own procedures for documenting and investigating consumer complaints.