FDA Policy/General

Latest FDA Warning Letters

Barox Co. Seongnam, Republic Of Korea (11/28): FDA inspected the drug manufacturing facility in May and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish written responsibilities and procedures applicable to the quality control unit. The firm also failed to exercise strict control over labeling issued for use in drug product labeling operations. And the firm failed to establish and follow written procedures regarding storage and warehousing of drug products. FDA placed the firm on Import Alert 66-40 on 11/8.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm627153.htm

Globus Medical Audubon, PA (10/30): FDA inspected the firm’s Human Biologics of Texas facility in April and documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/P). For example, the facility failed to investigate and document HCT/P deviations and trends of HCT/P deviations relating to core current good tissue practice requirements. The facility also failed to validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspection and tests.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm626576.htm

MiBo Medical Group Dallas, TX (11/20): FDA inspected the firm in May and cited GMP deficiencies with its manufacturing of the MiBo Thermoflo device. For example, the firm failed to establish procedures for design control. The firm also failed to establish procedures for corrective and preventive actions. Additionally, the firm failed to establish procedures to ensure all purchases or otherwise received product and services conform to specified requirements.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm627111.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