Food Safety

Pfizer blames Canadian EpiPen shortage on manufacturing complexities

22-Jan-2018 By Dan Stanton

Pfizer says ongoing remediation to the quality validation process at its supplier has resulted in a shortage of EpiPen auto-injectors in the 0.3 mg format.

US FDA seeks modest budget bump for FY2016

03-Feb-2015 By Zachary Brennan

The US Food and Drug Administration (FDA) is requesting a budget of $4.9bn for fiscal year (FY) 2016 – a 9% increase over the enacted budget for FY 2015. 

US FDA issues draft strategic priorities document

02-Jul-2014 By Gareth Macdonald

The US FDA has set emphasising the benefits of QbD, traceability and risk based manufacturing facility inspections as strategic priorities for the next four years in document published for consultation this week.

FDA issues import alerts against 22 Chinese heparin suppliers

23-Feb-2012

The US FDA has issued import alerts against 22 Chinese heparin suppliers it claims ship adulterated product.

FDA visiting Perrigo for post-warning letter reinspection

02-Mar-2011

US FDA inspectors have arrived at Perrigo’s Allegan, Michigan, US facility to re-inspect it as part of its follow-up to a warning letter last year.