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Aplicare landed an FDA warning letter after an inspection uncovered four significant GMP violations involving sterility controls and marketing claims for unapproved uses. Read More
The FDA served Wells Pharmacy Network with a six-observation Form 483 for failing to maintain adequate sterility controls and an acceptable state of repair at its Tennessee facility. Read More
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