Drugs

Gasco Industrial Cited for Repeat Manufacturing Deficiencies

FDA has cited Gasco Industrial Corp. for significant and repeat GMP deficiencies following a 2/17-27 inspection of the company's over-the-counter drug manufacturing facility in Gurabo, Puerto Rico. The Form FDA 483 indicates the inspection was conducted as a follow-up to deficiencies previously identified during a December 2023 inspection.

The agency's primary observation states that the firm's facilities and equipment controls remain inadequate to prevent contamination or product mix-ups. FDA investigators said Gasco failed to correct previously cited deficiencies involving cleaning validation and procedures for equipment shared between pharmaceutical and non-pharmaceutical manufacturing operations. According to the inspection report, the company continues to manufacture OTC drug products on equipment also used to produce industrial detergents and disinfectants while relying on draft cleaning validation protocols and procedures rather than finalized, validated processes.

FDA also documented extensive concerns involving the facility's water system and manufacturing controls. Investigators cited deficiencies in the design and monitoring of the purified water system, including potential dead legs, an inadequate quality monitoring program lacking scientifically justified sampling procedures, insufficient sampling frequency, and limited microbiological testing. The inspection additionally found that the company's process validation program remained in draft form and that equipment and cleaning validation activities had not been adequately completed.

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