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.

Diasol Inc. San Fernando, CA (9/28): FDA inspected the firm in June and cited GMP deficiencies with Dryasol liquid acid concentrates, Dryasol powder mixes, CitriSol concentrate, liquid Diasol acid concentrates, and liquid and powder sodium bicarbonate. For example, the firm failed to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. The firm also failed to establish and maintain procedures to control product that does not conform to specified requirements.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm579094.htm

Euro Diagnostica AB Skane, Sweden (9/20): FDA inspected the firm in January and cited GMP deficiencies with in vitro diagnostic devices, including the Euro-Diagnostica CCPoint. For example, the firm failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. It also failed to document all corrective and preventive action activities and their results.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578374.htm

Option Care Enterprises, Bannockburn, IL (9/28): FDA inspected the firm 9/2016 and cited serious deficiencies in its practices for producing sterile drug products. FDA investigators observed that operators demonstrated poor aseptic practices, such as moving rapidly within the ISO 5 area. In addition, the firm did not completely disinfect components and materials at each transition from areas of lower quality air to areas of higher quality (e.g., ISO 7 cleanroom to ISO 5 hood).
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578543.htm

Laveeza Bhatti Beverly Hills, CA (8/4): FDA inspected the clinical investigator’s site in 2016 and concluded that the individual did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects. For example, the clinical investigator failed to ensure that the investigation was conducted according to the investigational plan. The individual also failed to retain records required to be maintained for two years.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578987.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