Drugs

C&T Dream Co. CGMP Violations

An 11/6-11/10/2023 FDA inspection at the C&T Dream Co. drug manufacturing facility in Cheonan-si, South Korea, identified repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/11 Warning Letter says specific violations were:

failing to conduct at least one test to verify the identity of each component of a drug product;
failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
failing to maintain buildings used in the manufacture, processing, packing, or holding of a drug product in a good state of repair.

The letter notes that in a 2017 inspection, FDA cited similar observations. “You proposed specific remediations for these observations in your response,” it says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

The agency acknowledges the firm’s commitment to cease production of drugs for the U.S. market and says the company must notify FDA if it intends to resume drug production at this location or move to a new location.

The letter says FDA recommends that C&T engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. C&T was placed on an FDA Import Alert on 4/10.

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

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome