Roots Analysis
OCTOBER 24, 2023
Corticosteroids are produced by adrenal gland and play a role in controlling stress to decrease inflammation whereas, anabolic steroids regulate the manufacturing of testosterone in the testicles and the ovaries. This precaution is taken to prevent any potentially harmful contaminant from escaping the production area.
FDA Law Blog
JANUARY 1, 2024
Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.
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pharmaphorum
APRIL 6, 2021
AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses. . Emergent claims however that one batch of the vaccine simply failed quality controls, and no contamination took place.
The Pharma Data
MAY 4, 2021
billion, primarily driven by Pfizer CentreOne, Pfizer’s contract manufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., Hospital products, which grew 10% operationally to $2.3 down 7%, which reflects relatively stable U.S.
pharmaphorum
APRIL 22, 2021
The FDA’s closeout letter refers specifically to the cross-contamination incident that led to 15 million doses of the J&J shot being jettisoned when ingredients destined for AstraZeneca’s AZD1222 shot were accidentally mixed into vials of the J&J product. AZ’s vaccine meanwhile has yet to be approved in the US.
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