FDA 483 - Lucid Laboratories Private Limited - March 08, 2024

An FDA inspection of Lucid Laboratories Private Limited, a control testing laboratory in Hyderabad, India, from March 6-8, 2024, revealed significant deficiencies in its quality control unit. The firm failed to follow written procedures for documenting standards lists and deviated from specified test method parameters, including injection volumes, without notifying customers. These issues indicate a lack of adherence to established quality control processes.