Drugs

FDA cites Bausch + Lomb Manufacturing Facility

FDA has issued a Form 483 to Bausch + Lomb following a 3/12-20 inspection of the company's sterile drug manufacturing facility in Tampa, FL, identifying multiple observations involving complaint investigations, aseptic manufacturing practices, environmental monitoring, and quality system controls.

One observation focused on complaint handling. FDA investigators said the company failed to adequately investigate several adverse event complaints, including reports involving a metal shard found in an ophthalmic ointment, patient complaints describing burning, severe itching and a sensation of "shards of glass," and another complaint involving a severe reaction to an ophthalmic product. Investigators also cited the company for failing to submit a required Field Alert Report after a customer reported finding a black substance inside a drug container and cap.

The inspection also identified extensive concerns with aseptic processing practices. According to the Form 483, investigators observed operators moving rapidly through critical Grade A and Grade B cleanroom areas, improper sterile glove donning, personnel reaching over exposed containers, inappropriate handling of sterile tools during manufacturing interventions, and operators directly contacting sterile product components. FDA concluded that procedures intended to prevent microbiological contamination of sterile drug products were not adequately established or followed.

Additional observations addressed deficiencies in the firm's environmental monitoring program and quality oversight. FDA cited failures to investigate repeated environmental monitoring excursions, inadequate assessments of objectionable microorganisms recovered in manufacturing areas, and insufficient scientific justification supporting contamination control decisions.

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