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Pharmaceuticals / Inspections and Audits

FDA Warns Indiana Compounder Over Unapproved Drugs

Nov. 28, 2017

The FDA cited a compounding pharmacy in Indiana for producing unapproved drugs and for violations of sanitary standards.

The warning letter to Pharmakon Compounding Pharmacy, of Noblesville, said agency inspectors determined in an April and May 2016 inspection that Pharmakon did not qualify for the compounding exemption to certain FDA regulations because the pharmacy produced drugs that were not matched to prescriptions for individual patients.

That caused the pharmacy to run afoul of current good manufacturing practice standards, specifically by failing to establish and follow written procedures to prevent microbiological contamination of its products, by failing to establish adequate systems for maintaining equipment and monitoring environmental conditions for aseptic processing and by lacking appropriate laboratory testing on its ingredients and final products, the agency said.

The loss of the exemption also put Pharmakon in violation of labeling rules and of regulations prohibiting the production of unapproved drugs.

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