USFDA issues warning letter to Ipca Labs for 3 plants
It has been another tough week for some of
India's troubled drugmakers.
The company, which had already suspended
exports of products, mainly active pharma ingredients (APIs) and drug
formulations last following negative observations in inspections conducted by
the U.S. drug regulator at these factories and a subsequent import alert on
certain products.
Drug firm Ipca Laboratories has received a
warning letter from the USA health regulator for three facilities on which the
regulator had earlier imposed an import ban for not adhering to the good
manufacturing norms.
A January preapproval inspection at a
Wockhardt plant in Shendra determined that the plant is not yet ready for prime
time. The FDA issued a Form 483 with 9 observations, many of them to do with
data integrity, according to The Economic Times. The company claimed none of
the observations were "serious". "Therefore, since July 2014 the
company has not shipped any APls or formulations to USA market except the
products which are exempted from import alert", Ipca said in its notice.
Before the bans, Wockhardt derived more than half of its revenues from its USA
sales, but by previous year that was down to about 25% and falling.
The letter concerns the company's Ratlam and
SEZ Indore plants in central India, and the Piparia facility in western India,
IPCA said in a statement.
Apparently, it is not the only IPCA that is
facing the wrath from the FDA. The FDA usually posts such letters on its
website a week after issuing them to manufacturers, who need to respond to the
agency within 15 days with a plan on how they would work on fixing the issues.
"Since the inspection, the company has
regularly communicated with US FDA with periodic updates on remedial measures
undertaken and it is fully committed in resolving this issue at the
earliest", it added.
Source: http://leadercall.com/2016/02/usfda-issues-warning-letter-to-ipca-labs-for-3-plants/
Source: http://leadercall.com/2016/02/usfda-issues-warning-letter-to-ipca-labs-for-3-plants/
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