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The FDA appears to have picked up the pace of inspections after getting off to a slow start in January, issuing significantly more Form 483 inspection reports to manufacturers in March and continuing an upward trend from the previous month. Read More
The FDA has issued a warning letter to About Mineral, an Orange, Ca-based company that sells Puriton, a direct-to-consumer line of topical skin products which it claims have been tested and are effective against COVID-19. Read More
The U.S. Special Counsel has released details of a former FDA inspector’s allegations against the agency, including that it may have dropped the ball in an inspection of a Merck plant and possibly downgraded certain inspection findings without filing required documentation, claims he described as “troubling” in a letter to the White House. Read More
FDA investigators observed multiple problems at Emergent BioSolutions’ beleaguered Bayview facility in an April 12 to April 20 inspection prompted by a manufacturing mix-up for Johnson & Johnson (J&J)’s and AstraZeneca (AZ)’s COVID-19 vaccines, making it unlikely that the plant will be authorized to produce J&J doses anytime soon. Read More
The FDA appears to have picked up the pace of inspections after getting off to a slow start in January, issuing significantly more Form 483 inspection reports to manufacturers in March and continuing an upward trend from the previous month. Read More
FDA investigators observed multiple problems at Emergent BioSolutions’ beleaguered Bayview facility in an April 12 to April 20 inspection prompted by a manufacturing mix-up for Johnson & Johnson (J&J)’s and AstraZeneca (AZ)’s COVID-19 vaccines, making it unlikely that the plant will be authorized to produce J&J doses anytime soon. Read More
The FDA has issued a warning letter to About Mineral, an Orange, Ca-based company that sells Puriton, a direct-to-consumer line of topical skin products which it claims have been tested and are effective against COVID-19. Read More
The FDA sent a warning letter to Dibar Nutricional, an over-the-counter drug manufacturer in Morelia, Mexico, after a records-based inspection revealed significant lapses at the facility. Read More
The U.S. Special Counsel has released details of a former FDA inspector’s allegations against the agency, including that it may have dropped the ball in an inspection of a Merck plant and possibly downgraded certain inspection findings without filing required documentation, claims he described as “troubling” in a letter to the White House. Read More