FDA 483 - LNK International, Inc. - February 08, 2019

LNK International, Inc., an OTC drug manufacturer in Hauppauge, NY, received a Form 483 with three observations. The firm failed to thoroughly investigate out-of-specification microbial counts for a syrup product, leading to its release. Additionally, complaint investigation records were incomplete, and laboratory controls lacked appropriate testing procedures for impurities and dissolution for several combination drug products.