Drugs

CGMP Deviations at Zhejiang Tianyu Pharmaceutical

A 2/28-3/4 FDA inspection at Zhejiang Tianyu Pharmaceutical Co., Zhejiang Sheng, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 8/17 Warning Letter says the specific deviations were:

failing to extend investigations to other batches that may have been associated with a specific failure or deviations;
failing to establish an impurity profile for identified and unidentified impurities; and
failing to clean equipment at appropriate intervals to prevent build-up and carryover of contaminates and degradants where equipment is assigned to continuous production or campaign production of successive batches of the same intermediates and APIs.

The letter notes that similar observations were cited following a 4/8/19-4/12/19 inspection. “You proposed specific remediation for these observations in your response,” the letter says. “Repeated failures to address deficient operations demonstrate that executive management oversight and control is inadequate.”

FDA strongly recommends that the company retain a qualified consultant to assist it in meeting CGMP requirements.

Zhejiang Tianyu was told to correct all deviations 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

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