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The FDA cited active pharmaceutical ingredient (API) manufacturer Abbey Color for failing to properly qualify its suppliers and other quality lapses at its Philadelphia, PA facility. Read More
The FDA issued warning letters to two drugmakers and two contract testing facilities for serious quality failures, including testing violations, data integrity lapses and lax environmental monitoring. 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 announced. Read More
Among the many urgent priorities it faces during the pandemic, the FDA is devoting substantial resources to monitoring fraudulent COVID-19 products, issuing two dozen warning letters in May — including, for the first time, one to a company selling a fake vaccine. Read More
Among the many urgent priorities it faces during the pandemic, the FDA is devoting substantial resources to monitoring fraudulent COVID-19 products, issuing two dozen warning letters in May — including, for the first time, one to a company selling a fake vaccine. Read More
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