Drugs

Allergan’s Ireland Plant Hit With 483 After Inspection

FDA has cited multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland following an inspection last year, according to a just-released agency inspection report.

The Form 483 outlines concerns spanning testing procedures, cleaning validation and environmental monitoring in aseptic areas. Among the observations, FDA investigators say the company’s examination and testing practices did not adequately ensure that drug products and in-process materials met specifications. Inspectors cite insufficiently defined rejection limits for visual inspections, noting that limits were set for individual defect types but not for total critical, major or minor defects.

The agency also flags gaps in laboratory controls, including the absence of written procedures for endotoxin testing of certain in-process and finished drug products, as well as a lack of documentation governing sample handling timelines and tracking.

In addition, FDA says cleaning validation had not been conducted for some equipment components that come into indirect contact with sterile products during filling operations, raising concerns about potential contamination risks. Inspectors also point to shortcomings in environmental monitoring practices in aseptic processing areas, including unclear procedures for incubation and reading of monitoring samples.

Additionally, the report notes deficiencies in shipping validation, including the lack of standard operating procedures for packaging quality control and stability samples sent to external testing facilities.

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