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The FDA issued 483s to five drugmakers for inadequate good manufacturing practices observed by agency investigators during inspections of their facilities. Read More
FDA Commissioner Stephen Hahn said that the agency will resume domestic inspections this month using a new risk assessment system developed in response to the pandemic. Read More
The FDA handed Georgia-based contract manufacturer Pharma Tech Industries a Form 483 for good manufacturing practice violations at its Royston facility, including the release of drug products before obtaining test results and insufficient complaint investigations. Read More
Stason Pharmaceuticals did not ensure that capsules of the brain cancer drug temozolomide that it manufactured met dissolution attributes throughout their shelf life, and did not ensure proper computer security for its quality control data, the FDA said in a warning letter. Read More
Signa, a Mexican subsidiary of Canadian generic drugmaker Apotex, has received an FDA warning letter for failure to correct manufacturing problems for active pharmaceutical ingredients (API) that were later released into the U.S. market. Read More
The FDA has slapped Eosera with a Form 483 after finding the over-the-counter (OTC) ear-care product manufacturer failed to validate drug products and properly investigate bacterial contamination. Read More
Hospira’s McPherson, Kansas manufacturing plant was cited for numerous deficiencies found during an FDA inspection, many of them repeat issues from an earlier inspection. Read More
The FDA cited over-the-counter (OTC) drug manufacturer Eosera for failing to conduct process validations and other lapses at its Fort Worth, Texas facility. Read More