FDA Policy/General

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.

Cipla Limited, Mumbai, India (2/25): FDA inspected the company 9/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Cipla failed to clean, maintain, and 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 established requirements. It also failed to thoroughly investigate any discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been distributed. To view the letter, click here.

Gojo Industries, Cuyahoga Falls, OH (1/17): FDA states that because the firm’s Purell Healthcare Advanced Hand Sanitizer product line is intended for use as consumer and healthcare antiseptics it is considered an unapproved new drug. The letter contains examples of claims from the firm’s Web sites that indicate the products are intended to reduce or prevent disease from the Ebola virus, norovirus, and influenza. The products also are considered to be new drugs because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. To view the letter, click here.

Windlas Healthcare Private Limited, Dehradun, Uttarakhand, India (3/10): FDA inspected the company 8/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Windlas 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 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, and labeling. 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