U.S. Facilities Land Warning Letters Over GMP Deficiencies

August 31, 2016

Two U.S. pharmaceutical companies have received warning letters from the FDA for failing to meet GMP standards.

Brown’s Compounding Center, based in Colorado, has received a warning letter from the FDA after a 2015 inspection revealed significant deficiencies in the production of sterile drug products.

The FDA also found deficiencies at two facilities owned by Central Admixture Pharmacy Services in Pennsylvania and California.

At the Allentown, Pa., facility, investigators observed that procedures designed to prevent microbiological contamination of drug products purporting to be sterile were not established.

At the San Diego facility, investigators observed that testing and release of drug products for distribution do not include appropriate laboratory determinations.

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