Drugs

9 Observations in Fareva Amboise Inspection

FDA has released the form FDA-483 with nine observations from a 9/8-9/16 inspection at the Fareva Amboise sterile and non-sterile drug manufacturing facility in Indre Et Loire, France. The specific observations were:

procedures designed to prevent microbiological contamination of products purporting to be sterile do not include adequate validation of the aseptic process;
failure to establish and fully follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
failure to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
failure to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions;
batch production and control records do not include complete information relating to the production and control of each batch; and
procedures for the preparation of master production and control records are not described in a written procedure.

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