FDA 483 - Samjan Group, Inc. - March 03, 2022
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Sanjan Group Inc., dba PLS Analytical, a contract testing laboratory in East Brunswick, NJ, received a Form FDA 483 for significant deficiencies in its quality control and laboratory operations. The inspection revealed inadequate procedures for investigating Out of Specification (OOS) results and a lack of scientific justification for assigning expiration dates to laboratory chemicals. These issues indicate a failure to ensure the quality and purity of drug products.
ID · f953529b-6045-4d52-b1bf-5eedc182c494