Drugs

11 Observations from SCA Pharmaceuticals Inspection

FDA has released the FDA-483 issued following a 2/12-3/5 inspection at SCA Pharmaceuticals, Windsor, CT. Inspection observations listed on the form were:

the written stability program for drug products does not include reliable and meaningful test methods;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process;
there is a failure to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
each lot of components, drug product containers, and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit;
records are not kept for the maintenance and inspection of equipment;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair;
testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release;
the responsibilities and procedures applicable to the quality control unit are not fully followed; and
established test procedures are not followed.

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