FDA 483 - Eskayef Pharmaceuticals Limited - April 13, 2022

Eskayef Pharmaceuticals Limited, a sterile drug manufacturer in Gazipur, Bangladesh, was cited for significant deficiencies during an FDA inspection. Observations included failures in aseptic processing procedures, inadequate control over computerized systems and data integrity, and scientifically unsound investigations into out-of-specification results. The firm also demonstrated deficiencies in batch record documentation and quality control unit oversight.