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Pharmaceuticals / Inspections and Audits

FDA Warns Compounder It’s Not Exempt From Oversight

July 31, 2018

The FDA sent a warning letter to compounder Gipsco Investment cautioning that it’s not exempt from the agency’s oversight and was producing adulterated and misbranded products. The action stems from a June 2017 inspection of the Cleveland, Ohio, facility.

The FDA warned that drug products manufactured by the firm did not qualify for exemptions from current good manufacturing practice and labeling requirements under section 503A of the Food, Drug and Cosmetic Act. Specifically, the firm makes products using melatonin, even though drug products compounded using melatonin are ineligible for 503A exemptions.

“Melatonin is not the subject of an applicable USP or [National Formulary] monograph, is not a component of an FDA-approved human drug, and does not appear on the 503A bulks list” of exempt materials, the agency said.

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