Wockhardt gets another blast from US drug regulator FDA
28 Sep 2013
The US Food and Drug Administration (FDA), continuing its onslaught on generic drugs made in India, has made strong – and apparently justified - observations against Wockhardt's manufacturing plant at Chikalthana, citing major quality violations.
The FDA filing marks the second time this year that it noted violations of good manufacturing practices at a Wockhardt facility. In July this year, the FDA issued a warning letter as well as an import alert banning drugs made at Wockhardt's Waluj plant.
The Chikalthana document, or FDA Form 483, listed 16 observations about Wockhardt's factory in Chikalthana, raising serious concerns about quality control at the plant.
When FDA inspectors visited in July this facility, which produces generic copies of the heart tablet Toprol-XL, they found dilapidated buildings with blighted windows connected by flaking pipes and capped by a rusty roof.
They also claimed to have seen urine spilling over open drains, soiled uniforms and mould growing in a raw-material storage area.
Wockhardt has about 26 per cent of the US market for Toprol.
A Wockhardt spokesperson said, "We have responded to the observations made by the USFDA after an inspection of the Chikalthana facility and a response from them is awaited."
The facility was intended to serve as a production backup after the USFDA's action in July against the Waluj plant, near Aurangabad in Maharashtra.
For fiscal 2013, the Chikalthana facility (catering to the US and UK markets) contributed $230 million to the company's sales. This facility manufactures modified niche products including Toprol XL and Lamictal XL, among others.
The US FDA had advised Wockhardt to work with consultants on resolving the CGMP issues, conducting a detailed review of its site and oversee implementation of an action plan to meet FDA compliance.
