Drugs

CGMP Violations at China’s Concept Products

An 8/3-8/5/15 FDA inspection at Concept Products Limited, Tianjin, China, identified significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 7/26 Warning Letter. Specific violations observed during the inspection included:

failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release;
failing to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit;
failing to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates;
failing to establish written procedures for production and process controls, including validation protocols and reports, designed to assure that the firm’s drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
failing to establish written procedures for cleaning and maintaining equipment used in the manufacturing, processing, packaging, or holding of a drug product.

The letter said that the firm’s response acknowledged the significance of the CGMP observations and that it did not commit to any corrective actions regarding the violations observed in the inspection.

The company was told that if it resumed manufacturing drugs for the U.S. market, FDA strongly recommended engaging a qualified consultant to assist it in meeting CGMP requirements. It was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, along with supporting documentation and 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