Drugs

China’s Jinan Jinda Cited for API Deviations

A 5/30-6/1/16 FDA inspection at Jinan Jinda Pharmaceutical Chemistry Co., Zhangqiu City (Jinan), China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a just-released 2/24 Warning Letter. Specific deviations included:

failure of the firm’s quality unit to exercise its responsibility to ensure the API manufactured at the facility comply with CGMP and meet established specifications for quality and purity;
failure to adequately investigate out-of-specification results; and
failure to prevent unauthorized access or changes to data, and failure to provide adequate controls to prevent omission of data.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the letter says. “We acknowledge that you are using a consultant to audit your operation and assist in meeting FDA requirements.”

The firm was told to submit: (1) a comprehensive investigation into the extent of inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and (3) a management strategy for the company that includes details of its global corrective action and preventive action plan.

The firm was placed on an import alert 11/25/15.

Jinan Jinda was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence and 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