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The FDA hit Parsippany, N.J. contract manufacturer Davion with a Form 483 after an inspection revealed failures regarding its quality system and facility management. Read More
The FDA hit Indoco Remedies with a warning letter for significant CGMP violations related to data integrity following an inspection of its production facility in Goa, India. Read More
“We welcome the implementation of this agreement, which means authorities on both sides of the Atlantic will now be able to rely on each other’s inspection results,” said Guido Rasi, executive director of the European Medicines Agency. Read More
The World Health Organization (WHO) has released updated guidance for quality management system (QMS) requirements for national inspectorates aimed at aligning its content to international standards, the latest QMS principles and to expanding its scope. Read More
The FDA cited non-sterile human OTC and prescription drugmaker Epic Pharma for violations at its Laurelton, New York facility — including problems with conformance testing, product storage and the manufacturing of generic oxycodone hydrochloride. Read More
The storage room used for the substance was not labeled, and for part of the product’s manufacturing process, it had no label identifying its name, date and lot number. Read More
FDA hit High Chemical Company with a warning letter over CGMP deviations for active pharmaceutical ingredients (API) it manufactured at its Levittown, Pennsylvania facility. Read More
The FDA hit German bulk drug substance manufacturer Dynavax GmbH with a Form 483 over seven violations seen at its Düsseldorf facility, including inadequate corrective and preventive actions (CAPAs). Read More
The agency noted that the product’s labeling lists its active ingredient as diphenhydramine hydrochloride, but the NDC listing says the active ingredient is bromodiphenhydramine hydrochloride. Read More