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.

Anigan San Ramon, CA (7/25): FDA inspected the firm in April and cited GMP violations associated with its Class 2 Super Jennie and EvaCup reusable menstrual cups. For example, the firm failed to establish design controls. It also failed to establish procedures for design validation.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615066.htm

Milbar Laboratories East Haven, CT (7/23): FDA inspected the firm’s drug manufacturing facility 12/2017 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. It firm also failed to reject lot components that did not meet the appropriate written specification for identity, strength, quality, and purity.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm614399.htm

Yuki Gosei Kogyo Co. Tokyo, Japan (7/17): FDA inspected the firm 11/2018 and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, the firm failed to maintain complete data derived from all laboratory tests conducted to ensure the API complies with established specifications and standards. Its quality system was also an issue because it does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of drugs it manufactures.

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