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The FDA cited B. Braun Medical for failing to complete timely corrective and protective actions (CAPAs) following an inspection of its Irvine, Calif. facility. Read More
The FDA issued a warning letter to a drugmaker in India for lacking an adequate environmental monitoring system in its aseptic processing facility. Read More
The FDA cited Aurolife Pharma’s facility in Dayton, New Jersey for multiple violations, including lax measures to prevent contamination and other quality failures. Read More
The FDA cited Sunrise, Florida-based over-the-counter drugmaker Clientele for batch testing and other quality failures observed during an inspection. Read More
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