FDA 483 - Vortech Pharmaceuticals Ltd - November 06, 2024

Vortech Pharmaceuticals, Ltd in Dearborn, MI, was inspected and cited for significant deficiencies across multiple areas. Observations included inadequate cleaning, maintenance, and documentation of drug manufacturing equipment, as well as insufficient laboratory controls for water testing, specifically lacking validated methods for detecting Burkholderia cepacia Complex. Additionally, the firm failed to maintain proper records and procedures for returned drug products.