Drugs

CGMP Violations at South Korea’s Dermameal

A 3/25-3/29 FDA inspection at Dermameal Co., Gunpo-si Gyeonggi-do, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/12 Warning Letter says specific violations were:

failing to establish an adequate 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, and failing to establish and follow adequate written responsibilities and procedures applicable to the quality control unit;
failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates;
failing to conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failing to establish written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
failing to establish and follow adequate written procedures for cleaning and maintaining equipment.

FDA recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements. It also reminds Dermameal that it has responsibilities for the drugs it produces as a contract facility regardless of any agreements in place with the product owners.

Dermameal was placed on an import alert 7/19. It was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.

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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