FDA Policy/General

Latest FDA Warning Letters

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Braun Medical Irvine, CA (5/12): FDA inspected the firm in April and May and cited significant GMP violations with finished pharmaceuticals. For example, the firm’s quality control unit failed to establish and follow adequate written responsibilities and procedures. The unit was also not effectively exercising its responsibilities when investigating product defect complaints, manufacturing deviations, and adverse trends. FDA also cited the firm for not conducting prompt and thorough investigations with field action alerts.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm560634.htm

Med-Pharmex Pomona, CA (5/17): FDA inspected the firm in January and cited GMP violations associated with its animal drug product manufacturing (sterile injectables, oral suspensions, ointments, creams, non-sterile injectable and non-sterile topical ointments). For example, the firm failed to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile. Additionally, the firm failed to exercise appropriate controls over computer systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm560653.htm

Morhaim Pharmalab Miami, FL (5/16): FDA inspected the firm 9/2016 and documented serious GMP violations with its dietary supplements operations. For example, the firm failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision and for approving or rejecting any reprocessing. Also, the firm failed to establish component specifications for its Vital Procollagen dietary supplement product.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm559795.htm

Ocubright Tear Stain Remover, Inc. Aventura, FL (5/16): FDA inspected the firm in February and determined that its tear stain remover products are unapproved new animal drugs because they contain tylosin tartrate, and they are intended for use in the mitigation, treatment, or prevention of disease in animals, or to affect the structure or function of the body of animals.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm559809.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