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Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
The FDA issued X2 Zero a warning letter, after investigators observed several GMP violations at the company’s Texas facility and unspecified active ingredients in its supplements. Read More
The FDA handed Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards. Read More
Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to establish and maintain quality controls in a nine-observation Form 483. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) issued warning letters to two companies for publishing misleading advertisements that omitted risks and exaggerated benefits. Read More
The FDA issued a proposed rule adding six bulk drug substances to the list of materials that can be used in compounding, while removing four substances. Read More
The FDA has faulted Sanofi and Celgene for running misleading TV advertisements for two of their drugs and ordered the companies to pull the commercials. Read More
FDA investigators have cleared Akorn’s facility in Illinois for production, following a re-inspection that confirmed the company corrected several GMP deficiencies. Read More