The FDA served drug manufacturer Japanese drugmaker Eisai a Form 483 after an inspection of its Baltimore, Maryland facility revealed recordkeeping and quality control issues that led to incomplete data and unrestricted access to computers. 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
Customer Services Associates received a Form 483 for not developing written medical device reporting procedures, establishing procedures for corrective actions and reviewing complaints, and other violations. Read More
Nomax Inc. received a warning letter for failing to evaluate complaints, document corrective and preventive actions, and committing other violations. Read More
EuroPharma has received a GMP non-compliance statement from the Danish Medicines Agency (DMA). Read More
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