Drugs

CGMP, Other Violations at Chemolee Lab

A 1/12-2/13/15 FDA inspection at Chemolee Lab Corp., Irving, TX, found significant violations of current good manufacturing practice for finished pharmaceuticals and other violations, according to a 2/23 Warning Letter from the agency’s Dallas District Office. Specific violations included:
failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed, and failing to extend the investigation to other batches that may have been associated with the specific failure;· failing to clean, maintain and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements; failing to establish procedures for production and process control designed to assure that the drug products have the strength, quality, and purity they purport or are represented to possess; failing to have laboratory controls include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality, and purity; manufacturing and distributing several unapproved products that are considered drugs because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body; and offering several products for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners and thus cannot contain adequate directions written so that a layperson can use the products safely for their intended use.

The letter recommends that, due to the CGMP violations, the firm engage a third-party consultant with appropriate CGMP experience to assess its facility, procedures, processes, and systems to ensure that its drug products have appropriate identity, strength, quality, and purity. The company was told to take immediate action to correct the violations and to respond with a list of specific steps taken 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