Drugs

11 Observations on Atlas Pharmaceuticals FDA-483

FDA has released the FDA-483 issued following an 8/15-9/26 agency inspection at Atlas Pharmaceuticals, a Phoenix, AZ, outsourcing facility. The 15 inspection observations were:

failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
there is a lack of written procedures describing in sufficient detail the methods, equipment, and materials to be used for sanitation;
employees engaged in the manufacture, processing, packing, and holding of a drug product lack the education, training, and experience required to perform their assigned functions;
determinations of conformance to appropriate written specifications for acceptance are deficient for drug products;
laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality, and purity;
equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing, and holding;
drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected;
there is no written testing program designed to assess the stability characteristics of drug products; and
the labels of the facility’s drug products are deficient.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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