Drugs

11 Observations on Zhejiang Huahai FDA-483

FDA has released the FDA-483 issued after a 7/23-7/28 and 7/30-8/3 agency inspection at Zhejiang Huahai Pharmaceutical Co., Linhai, Zhejiang Province, China. The 11 observations on the form were:

failing to have an adequate change control system to evaluate all changes that may affect the production and control of intermediates or active pharmaceutical ingredients (API);
failing to have adequate validation of production processes, cleaning procedures, analytical methods, and in-process control test procedures;
failing to have an adequate system for managing quality to ensure confidence that API will meet intended specifications for quality and purity since the quality unit lacks written procedures and the authority and responsibility to ensure all critical deviations are thoroughly investigated;
failure of the quality unit to always fulfill its responsibility to release or reject all APIs;
failing of cleaning procedures to contain sufficient details to enable operators to clean each type of equipment in a reproducible and effective manner;
failing to have equipment used in the manufacture of intermediates and API that is of appropriate design and adequate size and suitably located for its intended use, cleaning, and maintenance;
schedules and procedures for preventive maintenance of equipment are not adequate or do not exist;
substances associated with the operation of equipment, such as lubricants, heating fluids, or coolants, are not always food grade lubricants and oils;
sampling plans and test procedures are not always scientifically sound and appropriate to ensure raw materials, intermediates, and APIs conform to established standards of quality;
failing to have an adequate on-going testing program to monitor the stability characteristics of APIs to confirm appropriate storage conditions and retest dates; and
production deviations are not always reported and evaluated and critical deviations are not always investigated and the conclusions recorded.

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