Monday August 10, 2020

Glaxo's Cork facility gets FDA warning over manufacturing

The US Food and Drug Administration (FDA) has warned GlaxoSmithKline that its Cork manufacturing plant has breached manufacturing regulations.

2nd April, 2014
FDA said it may refuse admission of articles manufactured at the Cork facility into the US.

The US Food and Drug Administration (FDA) has warned GlaxoSmithKline that its Cork manufacturing plant has breached manufacturing regulations.

In a warning letter posted online yesterday, the FDA told GlaxoSmithKline that it found significant violations of current good manufacturing practice (cGMP) regulations at the active pharmaceutical ingredient (API) manufacturing facility in Carrigaline in Co Cork.

The violations were found during an FDA inspection last October, the agency letter said. The agency said these deviations cause...

Subscribe from just €1 for the first month!

Exclusive offers:

All Digital Access + eReader

Trial

€1

Unlimited Access for 1 Month

Then €19.99 a month after the offer period.

Get basic
*New subscribers only
You can cancel any time.

Annual

€200

€149 For the 1st Year

Unlimited Access for 1 Year

You can cancel any time.

Quarterly

€55

€42

90 Day Pass

You can cancel any time.

2 Yearly

€315

€248

Unlimited Access for 2 Years

This product does not auto-renew

Team Pass

Get a Business Account for you and your team

Share this post

Related Stories

The best writing and and the biggest stories of 2019 from the Business Post

Richie Oakley | 7 months ago

Denis O’Brien is back in court, residents continue to fight the Council on halting site and a row surfaces in government over rent control proposals

Leanna Byrne | 4 years ago