483
Rpk Pharmaceuticals IncFDA 483 - Rpk Pharmaceuticals Inc - February 25, 2019
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Record Details
RPK Pharmaceuticals Inc. dba Pharmedix in Union City, CA, a repacker/relabeler, was inspected from February 25-28, 2019. The inspection revealed significant deficiencies related to employee training and adherence to sanitation procedures, specifically the use of expired hand sanitizer. These issues indicate a lack of control over personnel qualifications and environmental conditions that could impact drug product quality.
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ID · b07f1920-c28f-4f7f-b39f-845b70b9bbcc