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.

Firson Co. Chungcheongnam-do, Korea (8/31): FDA inspected the firm 11/2016 and cited it for significant GMP violations for finished pharmaceuticals. Agency investigators determined that the firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. It also failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575436.htm

Nova Homeopathic Therapeutics Albuquerque, NM (9/1): FDA inspected the firm in 10/2016 and cited significant GMP violations with 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 material, labeling, and drug products. The firm was also cited for failing to conduct at least one test to verify the identity of each component of a drug product.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575352.htm

Preservation Solutions Elkhorn, WI (8/21): FDA inspected the firm in April and cited GMP violations with its organ transplant preservation solutions. For example, the agency found that it failed to adequately validate, according to established procedures, a process whose results cannot be fully verified by subsequent inspection and test. It also failed to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm

Wuxi Medical Instrument Factory Jiangsu, China (9/7): FDA inspected the firm in March and cited it for significant GMP violations related to finished pharmaceuticals. For example, the firm failed to establish written procedures for production and process controls. It also failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality and purity. FDA recommended that the firm retain a GMP consultant to help it comply with regulations.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575785.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