FDA 483 - Precision Science Inc - September 23, 2022

Precision Science Inc. in Phoenix, AZ, a manufacturer of Type A medicated articles and drug products, was cited for significant deficiencies across multiple systems. The inspection revealed issues with equipment cleaning validation, cross-contamination controls, facility maintenance, a lack of a functional quality control unit, improper material handling, and critical data integrity failures in the laboratory. These observations indicate a broad lack of adherence to current good manufacturing practices.