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Pharmaceuticals / Inspections and Audits

FDA Cites Minneapolis Compounding Pharmacy Over Sanitation Issues

July 24, 2018

Minneapolis, Minnesota-based Fairview Compounding Pharmacy was hit with a Form 483 after an FDA inspection in April revealed serious sterilization deficiencies.

A pharmacy employee was seen using non-sterile aluminum foil to cover a non-sterile product and move it from an unclassified area into the ISO 5 aseptic processing area, where they continued aseptic processing of a product, Triple Agent UTZ (papav, phentol and alprost).

Certification documents for the firm’s ISO 5 aseptic processing areas did not describe the testing conditions, such as with operations ongoing, equipment in place and personnel present.

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