The FDA issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards. Source: Drug GMP…

Morton’s Salt was handed a Form 483 after an inspection revealed inadequate cleaning procedures and faulty manufacturing equipment. Source: Drug GMP Report

The FDA finalized guidance in December on suspect products and notification, describing when to file a report, and added example scenarios of fraudulent activity that would warrant alerting the agency,…

The FDA issued a warning letter to STI Pharma for serious violations of adverse event reporting requirements. Source: Drug GMP Report

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…

Spanish drugmaker Grifols is accused of defrauding the government of millions of dollars for promoting the use of its antithrombin drug, Thrombate III, in unapproved indications. Source: Drug GMP Report

The FDA issued warning letters to two international drug manufacturers for breaching GMP standards by failing to develop procedures to maintain the appropriate quality controls. Source: Drug GMP Report

Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows…

FDA’s San Juan district office has found numerous problems at a Baxter sterile drug manufacturing facility in Jayuya, Puerto Rico following a series of inspections in late August through early…

Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall batches of its drug products due to significant GMP deficiencies. Source: Drug…