FDAnews Drug Daily Bulletin

Quality Issues at SaveWay Compounding Lead to Warning Letter

Oct. 21, 2016

Multiple issues with manufacturing process at SaveWay Compounding Pharmacy, based in Delaware, are detailed in an FDA warning letter.

The investigation also found SaveWay was not receiving valid prescriptions for individual patients for a portion of the drug products it was producing.

During the investigation, officials discovered a failure to: establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile; establish an adequate system for cleaning and disinfecting rooms and equipment to produce aseptic conditions; and ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination.

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