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.

Dexcowin Co. Seoul, Korea (2/20): FDA inspected the firm 8/2017 and cited GMP deficiencies with manufactured portable dental diagnostic X-ray devices. For example, the firm failed to establish and maintain adequate procedures for implementing corrective and preventive actions. The firm also failed to establish and maintain adequate procedures for validating the device design. Additionally, the firm failed to establish and maintain adequate procedures for the identification, documentation, validation, or where appropriate verification, review, and approval of design changes before their implementation.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm599697.htm

Laser Dental Innovations San Jose, CA (2/27): FDA inspected the firm 12/2017 and cited GMP deficiencies for manufactured dental handpieces and laser fiber optic surgical devices. For example, the firm failed to establish procedures for implementing corrective and preventive actions. Additionally, the company failed to maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm599613.htm

Quali-Controle & Quali-Controle Meru, France (3/5): FDA inspected the drug contract testing laboratory and cited GMP deficiencies related to testing finished pharmaceuticals. For example, the firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods. Additionally, 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, whether or not the batch has already been distributed.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm599876.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

Read more

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