Biologics

FDA Posts Inspection Form From Emergent Bio

FDA has posted a five-observation Form FDA-483 from a 4/2020 inspection at troubled contract manufacturer Emergent Biosolutions’ Baltimore manufacturing facility. Last week, Johnson & Johnson sent quality and compliance experts to help Emergent after 15 million doses of J&J’s Covid-19 vaccine (see earlier story) were determined to not meet “quality standards.”

The inspection form provides a glimpse into some of the problems the facility has had to work through over the past year. For example, FDA inspectors found that Emergent did not exercise appropriate controls over computers or related systems to assure that changes in master production and control records are instituted by authorized personnel. The company was also cited for not following established specifications, test procedures and lab control mechanisms. And FDA said employees are not given training in the particular operations as part of their function and current good manufacturing practices.

One of the most glaring findings from the inspection seems to tie into errors by employees who mixed up materials/ingredients involved in J&J’s vaccine manufacturing. FDA inspectors said Emergent did not have separate or defined areas to prevent contamination or mix-ups, particularly regarding operations related to the holding of rejected components before disposition.

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