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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 October. Read More
The European Medicines Agency began reviewing data related to studies performed by Micro Therapeutic Research Labs at two sites in India, following a clinical practice inspection in February. Read More
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