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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
FDA Commissioner Stephen Hahn said Friday 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 issued a warning letter to active pharmaceutical ingredient (API) manufacturer Vega Life Sciences for violations of good manufacturing practices (cGMP) at its facility in southern India. Read More
The FDA cited Takeda biotech subsidiary Baxalta for a host of violations at its Thousand Oaks, California facility, including GMP lapses that could lead to product contamination. Read More
The FDA hit a La Habra, California compounding pharmacy with a warning letter for repeated violations, including dirty equipment and the presence of insects. Read More