Drugs

CGMP Violations Cited in Daewoo Warning

A 1/6-1/15 FDA inspection at the Daewoo Pharmaceutical Co. drug manufacturing facility in Busan, South Korea, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/2 Warning Letter says specific violations were:

failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or other such control systems necessary to prevent contamination or mix-ups in aseptic processing areas;
failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess;
failure of the firm’s quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity; and
failure to establish and follow adequate written procedures for cleaning and maintenance of equipment.

The letter says Daewoo’s quality systems are inadequate and acknowledges the company’s commitment to suspend all production of drugs at the facility and its deregistration as a drug manufacturer. FDA asks Daewoo to clarify whether it intends to resume manufacturing drugs for the U.S. market at the facility in the future.

The company was told to correct violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome