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The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
The FDA 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
The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. Read More
A month after the FDA announced a nationwide sweep that resulted in criminal and civil cases against 89 makers of dietary supplements, a former owner and operator of a Montana dietary supplement maker has been sentenced to prison for selling supplements in violation of two court orders. Read More
Observations cited in a Form 483 need to be reviewed carefully, because they represent — at least in the mind of that investigator — conditions that could make a drug adulterated. Read More
The FDA has hit three more compounders — two in California and one in North Carolina — with warning letters, bringing to 25 the number of warnings issued to this industry this year. Read More
On Tuesday, the FDA released the Oct. 22 warning letter issued to Sandoz sites in Kalwe and Turbhe, Maharashtra, India, which Sandoz had earlier hinted at during its third quarter earnings call. With the release of the warning letter, the extent of the data integrity issues are now known. Read More
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