FDA 483 - Lonza AG - March 28, 2023

This FDA Form 483 documents observations from an inspection of Lonza's facility. The primary observation concerns the inadequacy of laboratory records, specifically regarding the reporting of complete data from tests, examinations, and assays.

The firm failed to report exact values for Total Aerobic Microbial Count (TAMC) action limit results, as required by Lonza Test Method, Total Aerobic Microbial Count in Water, Doc. No.: CHVI-15464, Version: 11.0, Effective Date: 13-DEC-2022. An example cited is the review of Water Trend Test Results from 2019-2022, where action limit excursions were reported and trended only as "(b)(4) CFU/ml," with no exact counts available, recorded, or documented.

Additionally, the firm failed to report appropriate Environmental Monitoring action limit results as prescribed by Lonza. This indicates a deficiency in adhering to established specifications and standards for both water quality and environmental monitoring, impacting the assurance of product quality and compliance. The lack of exact data prevents proper trending and analysis of microbial counts, which is critical for maintaining a state of control within the manufacturing environment.