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As of mid-September, the FDA had conducted just 295 domestic and 44 foreign pharmaceutical inspections for fiscal year 2021, falling far short of its “best-case” scenario projections. Read More
Actavis Laboratories did not conduct adequate investigations when it found potentially harmful bacteria in some of its drug products and didn’t follow its written procedures in other quality-related areas, an FDA investigator observed during an inspection of the company’s drug manufacturing plant in Davie, Fla. Read More
Sterling Pharmaceutical Services drew the FDA’s attention for failure to document aseptic practices for employees and other quality lapses observed during an inspection at its Dupo, Ill., sterile drug manufacturing facility. Read More
The FDA rapped drugmaker Morton Grove Pharmaceuticals for failing to thoroughly investigate product discrepancies caused by microbial contamination and other quality lapses observed during a month-long inspection of its Illinois facility. Read More
As of Sept. 14, the FDA has conducted just 295 domestic and 44 foreign pharmaceutical inspections for fiscal year 2021, falling far short of its “best-case” scenario projections. Read More
The FDA observed several problems with the sterilization procedures in an inspection of Innoveix Pharmaceuticals’ facility in Addison, Texas. Read More
FDA investigators observed multiple quality lapses during an inspection at Tris Pharma’s Monmouth Junction, New Jersey facility and issued a 19-page inspection report. Read More
Despite contending that it didn’t need to submit investigational new drug (IND) applications for two COVID-19 trials of its novel glycan candidate, KB109, Kaleido Biosciences has received a warning letter from the FDA explaining that it did in fact need to submit one. Read More
Farmakeio Outsourcing of Southlake, Tex., drew a warning letter from the FDA on Aug. 3 for quality issues observed during an inspection in 2019. Read More
Japanese drugmaker Toyobo failed to adequately investigate why batches of a sterile injectable drug it makes were repeatedly contaminated with particles, the FDA said in a warning letter to the company. Read More
A Texas manufacturer of topical over-the-counter (OTC) drug products lacked an adequate quality control unit, the FDA said in a summary of observations during a spring inspection. Read More
A Las Vegas, Nev.-based drug compounder, AnazaoHealth, has received a warning letter from the FDA for marketing unapproved new drugs and for how it handles adverse event reports. Read More