Drugs

FDA Cites Sterile Processing, QC at Outsourcing Facility

FDA has identified significant deficiencies at BayCare Integrated Service Center, an outsourcing facility in Temple Terrace, Florida, following a March inspection, according to a just-released FDA Form 483. The inspection found weaknesses in environmental monitoring, cleaning validation, quality oversight, and batch release practices that could affect the sterility and quality of compounded drugs.

Investigators reported that the facility failed to adequately monitor aseptic processing conditions during active production. Critical ISO 5 areas were not routinely subjected to dynamic viable air monitoring, and supporting cleanroom areas were sampled less frequently than required by internal procedures.

The agency cited deficiencies in the firm’s cleaning and disinfection program, including a lack of evidence that its disinfectants are effective against bacterial and fungal spores. Environmental data showed repeated recovery of spore-forming organisms such as Bacillus and Paenibacillus dating back to 2023, with a notable increase in 2025.

FDA said the firm lacked robust written procedures to ensure product quality, particularly in visual inspection processes. The agency noted the absence of statistically valid sampling plans and inadequate controls for inspection conditions such as lighting and defect detection criteria. Additional issues included missing second-person verification of laboratory data and insufficient documentation practices.

The inspection also highlighted structural concerns within the company’s quality unit, where a small team was responsible for multiple overlapping functions, including environmental monitoring, investigations, batch review, and final product release. FDA investigators said this lack of segregation of duties undermines independent quality oversight.

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