Talk about acting guilty. Japanese drug manufacturer Nippon Fine Chemical was so concerned about US Food and Drug Administration (FDA) violations that the quality control manager literally created a “shoulder-to-shoulder” wall of people in an attempt to prevent an FDA inspector from entering portions of the lab used to analyze drugs for US distribution. The attempted inspection happened in December 2015 and was chronicled in an FDA warning letter to the company, issued last month. The inspection was prompted by customer complaints that Nippon’s drugs contained glass, metal, cardboard, hair, and at least one spider. Nippon primarily produces drugs for cancer patients including anti-cancer agents and pain management drugs.
As if deploying a human chain weren’t incriminating enough, Nippon’s quality assurance manager also prevented the FDA inspector from taking pictures of the equipment used to make drugs for US distribution. The FDA has since declared Nippon products altered and issued an import alert that allows for Nippon products to be detained upon import.
Given consumer’s complaints and the highly suspicious response to the FDA’s arrival, Nippon may be failing to comply with the FDA’s Current Good Manufacturing Practices (cGMP) requirements, a type of pharmaceutical fraud which can be a violation of the False Claims Act. The cGMP requirements are manufacturing rules, created and enforced by the FDA, that exist to ensure the strength, purity, and quality of manufactured drugs and medical devices. The goal of the requirements is to protect consumers from tainted, ineffective, or harmful drugs. A previous case involving cGMP violations—against Indian drug manufacturer RanBaxy Laboratories—settled for $500M in 2013. That case was brought to light by whistleblower Dinesh Thakur, who received a $48M award.
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