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Apothecus Pharmaceutical lacked proper safeguards to ensure that only authorized employees could change master production and control records, among other quality lapses observed by FDA investigators during a recent inspection of the company’s Hicksville, N.Y. facility. Read More
Contract drug manufacturer Hovione failed to properly maintain production equipment at its East Windsor, N.J., plant to prevent malfunctions from altering drug products, among other lapses, FDA investigators observed during a recent inspection. Read More
FDA investigators observed that Pine Pharmaceuticals’ outsourcing facility in Tonawanda, New York failed to properly investigate batch discrepancies, among other quality lapses, during an inspection that found repeat deficiencies seen in prior agency visits. Read More
Teva Pharmaceutical has stopped drug manufacturing at its Irvine, Calif., facility following a recent FDA inspection that revealed lapses, including possible mold contamination caused by water leaks. Read More
FDA investigators observed inadequate investigations into bacterial contamination, documentation lapses and other quality deficiencies during inspections of six drug facilities. 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
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 received a warning letter from the FDA explaining that it did in fact need to submit one. Read More
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