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The FDA issued a lengthy warning letter to Illinois-based HNC Products for a subpar out-of-specification investigation and the lack of validation testing for its over-the-counter sunscreen products. Read More
The FDA cited Sun Pharma’s New Jersey-based subsidiary Ohm Laboratories for batch testing and other quality failures following an inspection. Read More
The FDA issued a warning letter to an Oklahoma drug manufacturer Kalchem International for active pharmaceutical ingredient (API) labeling failures, a lack of API oversight, and other violations. Read More
Although the FDA has been especially vigilant towards websites selling sham COVID-19 products during the pandemic, it’s still keeping an eye out for unlawful opioid vendors, and it issued multiple warning letters last week to online firms that illegally sold opioid products. Read More
The European Medicines Agency’s suspended the marketing authorizations of generic drugs tested by Panexcell Clinical Laboratories at its site in Mumbai, India. Read More
A drug manufacturer in Bangalore, India, drew a warning letter from the FDA for failing to properly investigate contamination at its facility. Read More
A Mylan Laboratories active pharmaceutical ingredient (API) manufacturing facility in India drew a warning letter from the FDA for cleaning and other failures. Read More
The FDA hit Las Vegas compounder ACRx Specialty Pharmacy for poor aseptic practices and other GMP failures observed during an inspection last year. Read More
The FDA hit an Albuquerque, New Mexico firm with a warning letter after finding it committed drug repackaging violations and had no quality unit. Read More