The FDA slapped an Aquebogue, New York drug manufacturer with a warning letter over serious data integrity lapses and violations related to environmental and personnel monitoring. Read More

The FDA hit a Paterson, New Jersey contract testing laboratory with a warning letter for active pharmaceutical ingredient (API) testing violations. Read More

The FDA hit California drugmaker Blaine Labs with a warning letter for serious violations at its Santa Fe Springs facility, including the failure to investigate out-of-specification (OOS) test results. Read More

European officials cited Indian API maker Dishman Carbogen Amcis for serous quality failures found during an inspection of its facility in Gujarat. Read More

An FDA investigator found lapses in good manufacturing practices in an inspection of Time-Cap Laboratories’ drug manufacturing and repackaging facility in Farmingdale, New York. Read More

The FDA is working with the Centers for Disease Control and Prevention (CDC) to determine how it will restart routine on-site inspections of drug manufacturing facilities, the agency has announced. Read More

The FDA issued a warning letter to an Indian contract testing facility for repeated quality lapses and data integrity failures. Read More

FDA investigators found numerous GMP lapses at Innoveix Pharmaceuticals’ facility in Addison, Texas, including empty syringes, vials, gloves, and other materials left in a biosafety cabinet overnight. Read More

The FDA found a range of quality lapses during inspections at eight U.S.-based plants. Read More

The FDA hit online pharmacy Unitedpharmacies.md with a warning letter for marketing on its website unapproved and misbranded products as COVID-19 treatments. Read More

The FDA issued a warning letter to an Oregon compounder for lax aseptic practices observed during an inspection of its facility. Read More

Pfizer was taken to task in an FDA warning letter over testing violations at its Visakhapatnam, Andhra Pradesh sterile injectable drug facility. Read More