CP Medical, a maker of suppository chelating products and other drugs, was handed an eight-page, 22-observation Form 483 after an inspection of its Huntington Beach, Calif., plant found inadequate validation, testing, control and reprocessing.
Most notably, as of Sept. 13, 2011, the last date of inspection, the drugmaker had no written corrective and preventive action (CAPA) or complaint-handling procedures, the form states.
FDA investigators were not provided any records of studies and validations on the manufacturing process for certain products to show consistent conformity to specifications.
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