US FDA talks of DRL drug import ban if flaws are not fixed

The US Food and Drug Administration (US FDA), which had issued a warning letter to Dr Reddy's Laboratories over quality issues, has said it might withhold approval of the company's fresh drugs and stop import if no corrective action is taken.
The regulator said it had found several violations with regard to current good manufacturing practices (CGMP) at three of its plants.
"At Dr Reddy's Laboratories' facilities, we identified significant deviations from CGMP for manufacturing of active pharmaceutical ingredients (APIs)... We found significant violations of CGMP regulations for finished pharmaceuticals," US FDA noted.
"FDA strongly recommends that you evaluate global manufacturing operations to ensure compliance with CGMP regulations and requirements, comprehensively and immediately," the regulator said in its letter on November 5 addressed to Satish Reddy, DRL Chairman.

"Until you complete all corrections and FDA confirms your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product or API manufacturer."
"If you fail to correct these violations, under Section 801(a)(3) of the FD&C Act, 21 USC 381(a)(3), FDA may also refuse admission of articles into the United States...," it cautioned.

Earlier this month, the country's second-largest drug maker received a warning letter from the US drug regulator relating to two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana.
In response to the letter, DRL CEO G V Prasad had said the company is in the process of shifting some of the products from these plants to other facilities and considering third party assessment for its plants.

FDA said it's not satisfied with the replies given by Dr Reddy's on several occasions in the past one year.
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When contacted a DRL spokesperson said they are in the process of replying to USFDA's observations and will do so within the stipulated time.
The regulator has set a deadline for company to respond within 15 days from the date of receiving the letter.