FDA 483 - C-Care, LLC - February 27, 2025

C-Care, LLC, a drug manufacturer in Linthicum Heights, MD, was cited for significant deficiencies in its quality control system related to raw material management. The firm failed to establish the reliability of component supplier reports of analyses, specifically lacking procedures to qualify suppliers and validate Certificates of Analysis. Additionally, the company did not conduct required strength and purity testing for active pharmaceutical ingredients used in its products.