(MoneyControl.com) — Drug maker Dr. Reddy’s Laboratories on Tuesday said its Mexican arm has received a warning letter from the U.S. health regulator for violation of current goods manufacturing practice regulations.
Industrias Quimicas Falcon de Mexico SA has received a warning letter — on four counts — from the U.S. Food and Drug Administration, Dr Reddy’s said in a statement.
The company’s Mexico facility produces intermediates and active pharmaceutical ingredients.
The FDA had inspected Dr. Reddy’s Mexico facility in November 2010 and later sought certain explanations from the company. However, the regulator issued the warning letter dated June 3, citing “lack of corrective actions” by the firm.
“Dr. Reddy’s felt it responded to the 483 observations by implementing a number of corrective actions. However, the FDA has asked for additional data and corrective actions to the items listed in the warning letter,” the company said.
The Hyderabad, India-based firm said it takes these matters seriously and will respond to the FDA within the stipulated time frame.
“Dr. Reddy’s looks forward to working collaboratively with the FDA to resolve the matters contained in the warning letter,” it added.
The four counts include non-validation of analytical methods used to test APIs.
FDA has inspected the Mexico facility during November 8-11, 2010 and identified significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs.
“The inspection revealed that your firm had not validated the HPLC method for assay and related substances of fluocinolone acetonide (finished API steroid for human use),” the FDA’s letter said.
“This is just one example of numerous methods used by your firm that had not been validated according to approved procedures,” it added.
