Drugs

11 Violations in Bella Pharmaceuticals FDA-483

FDA has released the FDA-483 issued following a 6/10-7/18 inspection at Bella Pharmaceuticals, a Chicago, IL, outsourcing facility. The inspection observations were:

failing to establish, write, or follow procedures designed to prevent objectionable microorganisms in drug products required to be sterile;
failing to maintain documented production worksheets for any of the compounded sterile drug products shipped to customers;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
finished product testing for product release does not include required items;
buildings used in the manufacture, processing, packing, or holding of a drug product purporting to be sterile do not have the suitable size, construction, or location to facilitate cleaning, maintenance, and proper operations;
failing to establish or implement procedures to prevent mix-ups of drug products;
failing to have procedures or processes that provide sufficient control over bulk drug substances and components;
failing to have procedures or processes that provide sufficient control and storage over non-sterile glass vials prior to their use in compounding;
clothing of personnel engaged in the compounding, processing, packing, and holding of drug products purporting to be sterile is not appropriate for the duties they perform;
labeling on the facility’s drug products do not include information required by law.

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

Read more

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