FDA Policy/General

6 Observations on Innovative Compounding FDA-483

FDA has just released the FDA-483 issued following a 10/2-12/18/17 inspection at Innovative Intrathecal Solutions, doing business as Innovative Compounding Pharmacy, a Marietta, CA, producer of human and veterinary drug products. Specific observations on the form were:

procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process;
failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
failing to use results of stability testing in determining appropriate storage conditions and expiration dates; and
failing to laboratory test each batch of drug product purporting to be sterile to determine conformance to such requirements.

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