Drugs

CGMP Violations at China’s Longwood Medicine (Beijing)

A 9/25-9/29/17 FDA inspection at Longwood Medicine (Beijing) Co., Beijing, China, found significant violations of current good manufacturing practices (CGMP) for finished pharmaceuticals. An 8/27 Warning Letter says specific violations were:

failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, including drug products manufactured, processed, packed, or held under contract by another company, and failing to establish a quality unit with the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated; and
failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess.

The letter recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements following a comprehensive audit of its entire operation for CGMP compliance.

FDA also says that Longwood’s Biotronix Healthcare Chlora-Cleanze Proprep-I applicators are unapproved new drugs. It says the drug’s formulation is not consistent with the applicable tentative final monographs for pre-operative skin preparations and the active ingredient, chlorohexidine gluconate, is not covered under the OTC Drug Review for topical antimicrobial use in humans.

The company was told to respond with a list of specific steps 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

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