FDA 483 - Geneva Laboratories, Inc - June 03, 2021

On June 1-3, 2021, the FDA inspected Geneva Laboratories, Inc., a contract laboratory located at 1001 Proctor Dr, Elkhorn, WI 53121-2027. The inspection resulted in two observations detailed in Form FDA 483, issued to Lorena D. Drahnovsky, V.P. of Company Operations.

Observation 1 noted that the accuracy, sensitivity, specificity, and reproducibility of test methods have not been established. Specifically, the firm performs assays on tolnaftate API using a non-compendial method without supporting validation data.

Observation 2 identified a lack of appropriate controls over computers and related systems to ensure that changes in master production and control records or other records are instituted only by authorized personnel. Specifically, (b) (4) test results and FTIR test results are not protected from immediate deletion after acquisition. Additionally, the clock time on these two computer systems relies on (b) (4) and is not protected from accidental or intentional alteration. The document was issued by Carl A. MhFAMW(/1 t C S O and Gregory R. Brinsley, CSO, on June 3, 2021.