Data Manipulation Cited in Leiner Warning Letter
This article was originally published in The Gold Sheet
FDA's Atlanta District focused on data manipulation and inadequate testing procedures in an Aug. 28 warning letter to Leiner Health Products, Carson, Calif., based on a Jan. 22 to March 16 inspection of a Fort Mill, S.C., facility where Leiner manufactured over-the-counter products. The company has since moved OTC drug and nutritional product manufacturing operations to other facilities. During a Sept. 18 conference call, Leiner CEO Robert Kaminski attributed the firm's quality control issues to the conduct of certain Fort Mill employees, including some who have been dismissed
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