Drugs

API Deviations in Zhuhai Inspection

A 9/11-9/15/17 FDA inspection at Zhuhai United Laboratories, Zhuhai, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 6/27 Warning Letter says specific deviations were:

failing to adequately investigate and document out-of-specification results according to a procedure; and
failure of the quality unit to ensure that critical deviations are investigated and resolved.

The letter also raises additional agency concerns related to aseptic processing, including examples of incomplete data relating to the sterile manufacturing operations evaluated as part of the FDA pre-approval inspection. It also says that the company’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs the firm manufactures. Zhuhai was told to provide (1) a comprehensive investigation into the extent of inaccuracies in data, records, and reporting, including results of the data review for drugs distributed to the U.S.; (2) a current risk assessment of the potential for effects of the observed failures on the quality of the firm’s drugs; and (3) a management strategy for the company including details of a global corrective and preventive action plan.

FDA recommends that Zhuhai engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Zhuhai was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a timetable 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