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Pharmaceuticals / Inspections and Audits

FDA Raps California Drugmaker Over SOPs

Jan. 9, 2019

The FDA cited FMK Labs for deficiencies in its standard operating procedures during an Oct. 16-22 inspection of its Corona, California facility.

Some of the firm’s written SOPs lacked effective dates and revision dates. For example, an SOP on quality responsibilities had no revision date and included a blank page in place of its revision history. A procedure covering raw material control was provided to the FDA investigator in two separate copies — one with no effective date, and the other with no approvals, according to the Form 483.

The firm was unable to provide eight SOPs, including procedures for annual product review, pest control, supplier qualification, CAPAs, process deviation handling and out-of-specification products.

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