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

An FDA inspection conducted at Geneva Laboratories, Inc., a contract laboratory in Elkhorn, WI, from June 1-3, 2021, resulted in the issuance of a Form FDA 483. The inspection identified two key observations related to laboratory control and data integrity, indicating deviations from regulatory expectations likely under current Good Manufacturing Practices.

The first observation noted that the accuracy, sensitivity, specificity, and reproducibility of test methods had not been established. Specifically, the company was performing assays on tolnaftate Active Pharmaceutical Ingredient (API) using a non-compendial method without sufficient validation data. This raises concerns about the reliability and scientific soundness of product testing.

The second observation highlighted inadequate controls over computer systems to ensure data integrity. It was observed that test results, including (b)(4) and FTIR data, were not protected from deletion immediately after being obtained. Additionally, the clock times on these critical computer systems were not protected from accidental or intentional alteration, posing a risk to the authenticity and traceability of electronic records.

Geneva Laboratories, Inc. is expected to address these observations by developing and implementing comprehensive corrective and preventive actions. These actions should ensure that all test methods are appropriately validated and that computer systems incorporate robust controls to protect data integrity and prevent unauthorized changes or deletions.