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.

Baja Fur City of Industry, CA (12/13): FDA inspected the firm in July and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. The firm also failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of each batch. To view the letter, click here.

Dental-Kosmetik, Dresden, Germany (1/16): FDA inspected the company in July 15 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish written procedures for production and process controls. It also failed to establish and follow an adequate written testing program designed to assess the stability characteristics of its drug products. To view the letter, click here.

Draegar Medical Systems, Luebeck, Germany (1/17): FDA inspected the company in September and determined that modifications to its patient monitoring systems require a new 510(k). FDA also found the devices adulterated because they were not manufactured under Quality System regulation requirements. For example, the company failed to establish and maintain procedures for validating the device design that includes a risk analysis, where appropriate. Additionally, the firm failed to establish and maintain procedures for verifying that the device design meets design input requirements. To view the letter, click here.

Sunstar Guangzhou, Guangdong Sheng, China (1/22): FDA inspected the firm 6/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to perform, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications. Additionally, it failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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