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The FDA has issued a lengthy warning letter to Dr. Reddy’s Laboratories for three India facilities — two in Andhra Pradesh and one in Telangana — for several data integrity and GMP issues that the agency says “represent long-standing failures to adequately resolve significant manufacturing quality problems.” Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
The FDA has hit Life Support Development, a dietary supplement manufacturer and distributor, with a warning letter because its purported “hangover relief” product is considered an unapproved new drug. Read More
The U.S. Food and Drug Administration issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More
Contract manufacturer Neolpharma received an FDA Form 483 at its Puerto Rican facility for quality and production failures following a June 2 to 18 inspection. Read More
The Office of Pharmaceutical Quality is in the midst of its third pilot of integrated quality assessments, a team-based review process that will be the central tenet of OPQ’s review of drug applications. Read More
Health Canada has agreed to comply with a Canadian court ruling quashing the agency’s import ban on drugs from a generics manufacturer. In a Nov. 2 statement, Health Canada retracted an information update that prohibited imports from two Apotex manufacturing facilities in India. Read More
Novartis’ generics unit Sandoz received a warning letter from the FDA citing cGMP deficiencies for finished drugs at the company’s plants in Kalwe and Turbhe, India. Read More
Since January, the FDA has issued 16 drug GMP warning letters covering 19 facilities, and more than three-fourths of those letters cited data integrity issues. Read More
In the wake of an avalanche of FDA warnings to Indian drugmakers, Dr. Reddy’s Laboratories is the latest to be hit for GMP deficiencies at three of its Indian sites. Read More
To spur greater mutual inspection reliance between the FDA and EU, the agency and Congress are working to grant the EMA access to unredacted inspection reports. Read More