May 20 Indian generic drugmaker Sun
Pharmaceutical Industries Ltd's response to an import
ban on one of its plants lacked "sufficient corrective actions,"
the U.S. Food and Drug Administration said in a warning letter
published on Tuesday.
The FDA banned imports from Sun Pharma's Karkhadi plant in
Gujarat state in March, but the reason for the ban was not clear
at that time.
In the warning letter dated May 7 and posted on the FDA
website on Tuesday, the regulator said Sun Pharma failed to
ensure laboratory records had complete data and that
manufacturing staff had inadequate training and experience.
"Your firm frequently performs 'unofficial testing' of
samples, disregards the results, and reports results from
additional tests," the FDA said in the letter addressed to Sun
Pharma CEO Subramanian Kalyanasundaram. (link.reuters.com/pyx49v)
A Sun Pharma spokesman told Reuters on Tuesday that the
warning letter shows that the U.S. FDA does not agree with the
The Karkhadi plant, which makes the antibiotic
cephalosporin, is one of Sun Pharma's 25 manufacturing plants.
Sun Pharma, which is planning to buy its struggling rival
Ranbaxy Laboratories Ltd for $3.2 billion, had said in
March that the import ban would have negligible financial
The FDA has unleashed a wave of restrictions, warnings and
bans on Indian generic drug firms over the past one year, citing
serious manufacturing and quality control problems.
(Reporting by Esha Dey in Bangalore and Zeba Siddiqui in
Mumbai; Editing by Sriraj Kalluvila)