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.

Lernapharm (Loris) Inc. Montreal, Canada (9/4): FDA inspected the firm 12/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. It also failed to conduct thorough investigations into customer complaints involving sterile drug products which purport to be sterile. Additionally, the firm did not evaluate all potential causes for customer complaints or extend the investigation to other potentially affected batches and other products.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619590.htm

Longood Medicine Beijing, China (8/27): FDA inspected the firm 9/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm 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, labeling, and drug products, including drug products manufactured, processed, packed or held under contract by another company. The inspection also took issue with the firm’s contractor oversight. For example, it failed to ensure that a third-party contractor uses a validated terminal sterilization process.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619198.htm

Medtronic Minneapolis, MN (8/23): FDA inspected the firm’s Juncos, Puerto Rico, and cited Qualty System violations with its implantable pacemakers, implantable cardioverter defibrillators, cardiac resynchronization devices, and other related products. For example, the firm failed to validate required processes. It also failed to document activities in the device history record.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619206.htm

Medtronic Minneapolis, MN (7/30): FDA inspected Medtronic’s Cardiac Rhythm and Heart Failure business in Mounds View, MN 5/2018 and cited Quality System violations. For example, the firm failed to establish adequate procedures for design transfer. The firm also failed to establish adequate procedures for changes to a production process. Additionally, FDA noted that Medtronic’s Corrective and Preventive Action efforts did not commensurate with risk or were conducted as required by its procedure.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619199.htm

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