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.

Deva Holding, Istanbul, Turkey (8/6): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to perform operations related to the manufacture, processing, and packing of penicillin in facilities separate from those used for other drug products. Deva also failed to test non-penicillin drug products for the presence of penicillin when a reasonable possibility existed that the non-penicillin drug product had been exposed to cross-contamination with penicillin. To view the letter, click here.

Polymer Technology Systems, Indianapolis, IN (7/31): FDA inspected the in vitro diagnostic medical devices maker in February and cited significant GMP violations. For example, the company failed to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. It also failed to adequately validate a process whose results cannot be fully verified by subsequent inspection and test. To view the letter, click here.

TG United, Brooksville, FL (8/1): FDA inspected the firm in February and cited GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. The company also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. 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