Search FDA Inspections, Sites, and Warning Letters on the FDAzilla Platform

MHRA GMP 2018

2018 MHRA GMP Inspection Deficiencies

Provided is an overview of MHRA’s 2018 GMP inspection deficiencies parsed by Annex and Chapter, and Critical and Major deficiencies.

Recent Posts

How Key Pharma and Device Executives Are Developing the Next Generation of Quality Professionals and Leaders

A team comprising over a dozen chief quality officers (CQOs) representing the medical device, pharmaceutical, animal health, and consumer healthcare industries has pooled its collective passion and wisdom – with input from FDA and other drug and device regulatory agencies – to establish and implement an innovative education curriculum that will help develop the next generation of scientists entering the industry.

READ MORE

Enforcement Actions Against Sartan Manufacturers

Health authorities worldwide have overseen the recall of many ‘sartan’ products in the past few years.  These recalls began in the US as early as 2013 with a recall of product by Teva Pharmaceuticals. Here, we address some of the enforcement actions taken against a few of the notable players in this series of events.

READ MORE
yellow pills

Repeat Deficiencies in Lupin Limited Warning Letters

When observations are identified during an inspection, it is FDA’s expectation that a firm will remediate the issues. This expectation is even more important if a firm receives a warning letter. Lupin Limited (India) seems to have come up short on both accounts.

READ MORE

How Key Pharma and Device Executives Are Developing the Next Generation of Quality Professionals and Leaders

A team comprising over a dozen chief quality officers (CQOs) representing the medical device, pharmaceutical, animal health, and consumer healthcare industries has pooled its collective passion and wisdom – with input from FDA and other drug and device regulatory agencies – to establish and implement an innovative education curriculum that will help develop the next generation of scientists entering the industry.

Read More »

Enforcement Actions Against Sartan Manufacturers

Health authorities worldwide have overseen the recall of many ‘sartan’ products in the past few years.  These recalls began in the US as early as 2013 with a recall of product by Teva Pharmaceuticals. Here, we address some of the enforcement actions taken against a few of the notable players in this series of events.

Read More »