Drugs

CGMP Violations at Korea’s Dae Young Foods

A 3/13-3/17 FDA inspection at Dae Young Foods Company, Seoul, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/20 Warning Letter. Specific violations cited in the letter were:

failing to visually examine each container of components for appropriate labeling as to contents upon receipt and before acceptance;
failing to conduct at least one test to verify the identity of each component of a drug product, and failing to test each component for conformity with all appropriate written specifications for purity, strength, and quality; and
failing to establish an adequate quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA also found that the firm’s Smoker’s Appetite Relief homeopathic product is a drug because it is intended to diagnose, cure, mitigate, treat, or prevent disease, and is misbranded because there are numerous ingredients included in the product that are not declared on the label, as well as ingredients listed on the label that are not in the product.

The letter notes that as a contractor, Dae Young has a quality agreement with its customer regarding the manufacture of a redacted product. “You are responsible for the quality of drugs you produce as a contract facility, regardless of the quality agreements in place,” FDA says. “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant … to assist your firm in meeting CGMP requirements.”

Dae Young was told to respond with a list of actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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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