Drugs

CGMP Violations at Phase 4 Pharmaceutical

A 4/26-5/2/17 FDA inspection at Phase 4 Pharmaceutical, Aventura, FL, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 4/18 Warning Letter says specific violations were:

failing to establish a 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;
failing to establish and follow written procedures designed to assure that correct labels, labeling, and packaging materials are used for the products, including procedures to prevent mix-ups and cross-contamination by physical or spatial separation from operations on other drug products;
failing to establish a system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary; and
failing to ensure that drug products bear an expiration date that is supported by appropriate stability testing.

The letter says FDA tested OTC transdermal patch products the company repackages and found multiple samples to be sub-potent with no active ingredient content. The agency testing also found nondeclared ingredients (DHEA and pregnenolone) in samples of the firm’s Power Patch.

Phase 4 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