Drugs

API Deviations in Yicheng Goto Inspection

An FDA 9/11-9/14/17 inspection at Yicheng Goto Pharmaceuticals, Hubei Province, China, found significant deviations of current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 7/26 Warning Letter says the specific deviations were:

failing to adequately validate the process for cleaning and maintaining equipment;
failing to ensure that all test procedures are scientifically sound and appropriate to ensure that the API conform to established standards of quality and purity;
failing to design a documented stability program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates; and
failing to demonstrate that the manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.

The letter says similar observations were reported in inspections in 2011 and 2015. “These repeated failures demonstrate that your management’s oversight and control over the manufacture of intermediaries and API is inadequate,” it says. “Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements. We also recommend that the third party perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and effectiveness of any corrective action and preventive actions you have implemented before you pursue resolution of your firm’s compliance status with FDA.”

Yicheng Goto was placed on an import alert 1/10. The company 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.

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

Read more

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