Tag Archives: Facility

FDA faults Biocon small molecule API facility during preapproval review

The FDA has found a handful of issues with Biocon’s small molecule API facility in Bengaluru, India. The company today reported that the agency issued a Form 483 with five observations following a preapproval and good manufacturing practices inspection last week of its small molecule API facility. It didn’t say what product it is hoping to get… Read More: FDA faults Biocon small molecule API facility during preapproval review »

Novartis’ new cell therapy facility could ease manufacturing squeeze for CAR-T med Kymriah

Novartis’ big push into cell and gene therapy hasn’t been the smoothest of rides, with a data manipulation scandal hamstringing Zolgensma and manufacturing concerns hurting CAR-T cancer therapy Kymriah. Could a new European facility help turn around the latter’s production bottleneck? Novartis last week opened its newest cell and gene therapy facility in Stein, Switzerland,… Read More: Novartis’ new cell therapy facility could ease manufacturing squeeze for… »

Phishing attack risks data of 30,000 patients of Mississippi facility

Memorial Hospital at Gulfport in Mississippi is notifying patients that protected health information may have been compromised by a phishing attack. The facility reported that access to the information was achieved by an attack on an employee’s email account on December 6, 2018. A phishing attack occurs when a hacker sends an email that appears… Read More: Phishing attack risks data of 30,000 patients of Mississippi facility »

New Jersey urges patients at facility to check for HIV infections

NEW YORK (Reuters) – New Jersey health officials have urged more than 3,700 former patients of a surgical facility to get blood tests “out of an abundance of caution,” because they may have been exposed to HIV, hepatitis B and hepatitis C. Although the risk of infection is low, patients who had procedures at the… Read More: New Jersey urges patients at facility to check for HIV… »