Drugs

FDA Warns Canada’s Deserving Health International

A 7/10-7/14/17 FDA inspection at Deserving Health International, Richmond, British Columbia, Canada, a manufacturer of sterile homeopathic eye drops, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. Specific violations cited in a 12/18/17 Warning Letter were:

failing to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failing to establish an adequate quality control unit and procedures applicable to the 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 conduct at least one test to verify the identity of each component of a drug product and failing to test each component for conformity with all appropriate written specifications for purity, strength, and quality; and
failing to perform, 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, and to conduct appropriate laboratory testing for each batch of drug product required to be free of objectionable microorganisms.

“Based upon the nature of the violations we identified at your firm,” the letter says, “We recommend engaging a consultant … to assist your firm in meeting CGMP requirements. It is essential that you initiate a comprehensive assessment of your company’s manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements.”

The firm agreed 9/2017 to recall its Symbio Muc Eye Drops 5X due to a lack of sterility assurance and was placed on import alert 11/2/17. It was told to respond with a list of 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

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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