Drugs

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Cosmaceutical Research Lab, Surrey, Canada (5/29): FDA inspected the firm 11/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. It also failed to establish laboratory controls including scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. To view the letter, click here.

Klarity Medical Products, Newark, OH, (6/8): FDA inspected the company in February and found multiple violations related to the firm’s work as a specification developer and manufacturer of various body support devices used during patient radiation therapy treatment. For example, Klarity failed to submit required reports within 10 working days of initiating a correction or removal. It also failed to establish and maintain procedures for implementing corrective and preventive action. To view the letter, click here.

Fenwal International, Maricao, Puerto Rico (5/14): FDA inspected the company 9/2019 and found GMP deviations related to the manufacture of the firm’s blood-pack units with and without in-line leukoreduction filters, as well as InterSol, a platelet additive solution. For example, the company’s microbiology laboratory did not accurately document test results. FDA says the deviations indicate that the company’s quality control unit is not fulfilling its responsibility to assure the identity, strength, quality, and purity of its drug products. To view the letter, click here.

Takeda Pharmaceutical, Tokyo, Japan (6/9): FDA inspected the company 11/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures. Takeda also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. Additionally, it failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether the batch has already been distributed. To view the letter, click here.

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