LNK International, Inc.February 8, 2019

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

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Record Details

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.

Company: LNK International, Inc.
Inspection Date: February 8, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
Person: Guerlain Ulysse (Investigator)

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ID · 498a2eef-e64f-468b-9ece-7cdf978b5fb6