FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Minnesota Drugmaker Cited for Cleaning Deficiencies

May 6, 2019
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The FDA hit Minnesota generic drug manufacturer Upsher Smith Laboratories with a Form 483 over cleaning and batch production violations at its Plymouth facility.

In a Nov. 26-Dec. 19, 2018 inspection, the FDA noted deficiencies in scheduling of equipment cleaning and maintenance procedures. The firm failed to conduct adequate cleaning studies and to clearly define dirty and clean hold times for manufacturing equipment in its standard operating procedures, the agency said.

The investigator noted that the cleaning of discolored ceiling tiles in the facility’s liquid preparation room was not recorded in the equipment/room log. In addition, cleaning and maintenance staff failed to date and sign the equipment cleaning and use log.

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