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.

Glenmark Pharmaceuticals, Mumbai, India (10/3): FDA inspected the firm in April and cited significant GMP violations for finished pharmaceuticals. For example, Glenmark failed to thoroughly investigate multiple complaints about the grittiness of a product cream. The company also failed to investigate multiple out-of-specification test results for critical product attributes. To view the letter, click here.

Torrent Pharmaceuticals, Gujarat, India (10/8): FDA inspected the firm in April and cited significant GMP violations for finished pharmaceuticals. For example, Torrent did not appropriately follow its written and approved process validation protocol which required quality attributes to be met for three consecutive batches to qualify an alternate active pharmaceutical ingredient. Additionally, the company did not adequately investigate out-of-specification testing results. To view the letter, click here.

Coral Pharmaceuticals, Freeport City, Grand Bahamas (10/9): FDA inspected the firm in May and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written procedures for production and process controls. Additionally, Coral failed 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. To view the letter, click here.

Denterprise International, Ormond Beach, FL (10/9): FDA inspected the firm’s medical device operations and cited GMP violations with its FlashRay dental X-ray sensor and the MobileX, Model T-100, dental X-ray system. For example, Denterprise failed to establish procedures for design controls. The company also failed to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements. Additionally, its complaint records do not include the nature of the complaint with sufficient detail to fully support the findings of each investigation and the actions taken in response. 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