FDA 483 - Samjan Group, Inc. - May 28, 2021

Samjan Group Inc. dba PLS Analytical, a contract testing laboratory in East Brunswick, NJ, received a Form 483 with seven observations following an FDA inspection from May 10-28, 2021. The observations primarily highlight significant deficiencies in laboratory controls, including inadequate investigations, insufficient employee training, unvalidated test procedures, and poor data integrity practices. These issues raise concerns about the reliability of analytical data and the quality assurance system for drug products.