Terrugem, Portugal-based Hikma Farmaceutica has received a close-out letter from FDA indicating that the agency believes the firm has successfully addressed the violations contained in its October 2014 warning letter that resulted from a March 2014 inspection. The close-out letter was based on the firm’s responses to FDA. The agency notes in the letter that “future inspections and regulatory activities will further assess the adequacy and sustainability of the corrections.” Violations cited in the letter were related to EM excursion investigations and the associated CAPAs, and the firm’s quality SOPs (IPQ “Monthly Update”November 2014, p. 39). Hikma develops, manufactures and markets a broad range of both branded and non-branded generic and in-licensed drugs.
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