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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
An over the counter (OTC) drugmaker in Turkey drew a warning letter from the FDA for inadequate testing of its finished drug product for export to the United States and for numerous other violations of current good manufacturing practices. Read More
In a March 22 to April 12 inspection of a sterile drug manufacturing facility in Santa Barbara, Calif., the FDA investigator observed the presence of non-microbial contamination in the storage and mixing room, among other quality issues. 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
FDA investigators observed during a March 24 to April 9 inspection of Ampak Chemical’s Carson, Calif., facility that it lacked a quality unit to oversee drug manufacturing. Read More
An FDA inspection of an Eli Lilly manufacturing facility in Indianapolis, Ind., earlier this year observed inadequate environmental monitoring in aseptic processing areas, among other quality lapses, the agency said in a Form 483 inspection report that was just publicly released. Read More