Italian regulatory authorities have ordered a ban on drug substances and bulk products manufactured by Antibióticos Do Brasil after an inspection revealed several GMP deficiencies, ranging from data integrity to…
FDA served Porton Biopharma a warning letter after an inspection revealed failures to notify the agency of changes affecting drugs, and failing to follow procedures to prevent microbiological contamination. Source:…
The FDA issued Form 483s to two drug manufacturers for data integrity and laboratory issues. 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…
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