Drugs

API Violations in Chongqing Lummy Inspection

A 3/14-16 FDA inspection at Chongqing Lummy Pharmaceutical Co., Chongqing, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients, according to a 6/21 Warning Letter. Specific violations noted in the letter included:

failing to prevent unauthorized access or changes to data and failing to provide adequate controls to prevent manipulation and omission of data; and
failing to document manufacturing operations at the time they are performed.

The firm’s responses were inadequate, the letter says. The company was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence. “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. “In your firm’s 3/31 response, you admitted that personnel were not properly trained and that you planned to hire a consultant to perform comprehensive CGMP training. You committed to recall your API in 4/29 correspondence.”

The agency says it has received confirmation of a voluntary recall of API from U.S. customers and adds, “we strongly recommend that you retain a qualified consultant to assist in your remediation.” The company was told to submit (1) a comprehensive investigation into the extent of the inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of its drugs; and (3) a management strategy including details of its global corrective action and preventive action plan.

Because of the inspection findings, the firm was placed on an import alert on 4/19.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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