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.

Centurion Medical Products, Williamston, MI (6/11): FDA inspected the company 8/2019 and cited sterile convenience kits that have not been approved or cleared by FDA. The inspection also found that Centurion failed to establish and maintain procedures to control the design of the device to ensure that specified design requirements were met. It also failed to establish and maintain procedures for implementing corrective and preventive actions. To view the letter, click here.

Signa SA de CV facility, Toluca De Lerdo, Mexico (7/14): FDA inspected the firm 12/2019 and found significant GMP deviations for active pharmaceutical ingredients. The agency says Signa failed to adequately investigate out-of-specification results and to implement appropriate corrective action. The letter also acknowledges that Signa initiated efforts to remediate and improve its investigation programs and says the company response lacked adequate details on the remediation approach and the scope of its assessment was insufficient. To view the letter, click here.

Stason Pharmaceuticals, Irvine, CA (7/8): FDA inspected the firm 10/2019 and found significant GMP violations for finished pharmaceuticals. For example, Stason failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed. It also failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel instituted changes in master production and control records or other records. 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