Drugs

Sichuan Friendly Pharmaceutical CGMP Deviations

A 10/23-10/27/17 FDA inspection at Sichuan Friendly Pharmaceutical Co., Sichuan, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 6/22 Warning Letter says the specific deviations were:

failing to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that the active pharmaceutical ingredients conform to established standards of quality and purity;
failing to adequately validate written procedures for the cleaning and maintenance of equipment;
failing to design a documented, ongoing stability testing program to monitor the stability characteristics of active pharmaceutical ingredients and to use the results to confirm appropriate storage conditions and retest or expiry dates; and
failing to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and to have adequate controls to prevent omission of data.

The letter recommends that the company retain a qualified consultant to perform a comprehensive audit of the company’s entire operation for CGMP compliance and evaluate the completeness and effectiveness of any corrective and preventive actions it implements before the company pursues resolution of its compliance status with FDA. The company was placed on an import alert 3/22.

Sichuan was told to respond with a list of actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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