FDA slaps Dr. Reddy's with a Form 483

The FDA has slapped Dr. Reddy's Laboratories with a Form 483 letter, outlining concerns about the drugmaker's manufacturing plant in southern India, the company said.

The Indian drugmaker told Reuters it received "inspectional observations" from the U.S. regulatory agency following an inspection at the plant. No specific FDA concerns were cited by the company. The plant is located in the country's state of Andhra Pradesh.

The company told the news agency there is currently no "activity" at the plant, which makes drug ingredients, adding that it was "committed to" responding to the FDA letter and will immediately implement remedial measures to correct the issues cited by the agency.

The action comes as a number of India's largest manufacturers have had troubles with the FDA. Last month, Dr. Reddy's was on the positive side of these kinds of issues. A U.S. federal judge turned down competitor Ranbaxy Laboratories' request for a temporary restraining order against the FDA after the agency revoked the Indian drugmaker's approvals to make generics of AstraZeneca's ($AZN) blockbuster Nexium and Roche's ($RHHBY) antiviral Valcyte because of manufacturing shortcomings. The FDA had granted Dr. Reddy's and Endo Health Solutions ($ENDP) permission to manufacture generic Valcyte, and Ranbaxy had hoped to stop that from happening.

Dr. Reddy's is one of the Indian drugmakers that has learned from Ranbaxy's pitfalls, investing in its Indian plants to get workers less directly involved in production and so reduce the chance for human error. The company has said it invested $147 million in plants and equipment to improve its drugmaking process.

- see the Reuters story

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