Drugs

3 CGMP Violations at Korea’s Samchundang Pharm

A 10/17-10/25/19 FDA inspection at Samchundang Pharm Co., Seoul, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 5/13 Warning Letter says specific violations were:

failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods;
failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas; and
failing to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions.

FDA acknowledges the company’s commitment to stop producing drugs for the U.S. market and says that if the firm decides to recommence manufacturing drugs for the U.S. market it must notify FDA before starting operations.

If Samchundang decides to resume drug manufacturing for the U.S. market, FDA recommends that it retain a qualified consultant to assist it in meeting CGMP requirements.

The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for implementation of the actions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome