US FDA questions facility design in Warning Letter for Emcure's Pune plant

The US Food and Drug Administration (FDA) published details of its January 2015 visit to Emcure’s Hinjwadi, Pune facility last week​, outlining a number of current good manufacturing practice (cGMP) violations. 

Among the issues, the FDA noted said the poor application of aseptic processing techniques. It also questioned the design of the facility, suggesting it could represent a contamination risk.

“For example, we observed an employee crawling under filling equipment to get to the area where he performed other critical operations.”​

The Agency also cited an example of water from the bottom of an ISO 5 (Grade A) filling machine being collected with a cup on the ground and used to lubricate equipment.

Other violations included failures to establish laboratory controls, the use of unreliable environmental monitoring (EM) and personnel monitoring (PM) data for aseptic operations. The FDA also reported observations of poor documentation practices during production and in-process testing.

Emcure’s cGMP violation record​

The facility has a history of compliance problems. 

In 2014​, nearly 23,000 bottles of methyldopa tablets made at the site for generics giant Teva were recalled after it was discovered that laboratory testing was not being conducted in accordance with cGMP.

And in February 2015​, two lots of Sagent’s Atracurium Besylate – an injectable agent used during surgery - also made at the plant were recalled. Sagent respnded by taking production in-house.

Months later, the FDA imposed an import alert​ on the facility that banned Emcure from shipping nearly all drugs made there to the US.

Emcure did not respond to requests for comment from this publication.