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An FDA inspection of Isomeric Pharmacy’s Salt Lake City facility revealed several GMP violations that rendered its drugs adulterated and resulted in a warning letter. Read More
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. Read More
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