# FDA 483 - Eli Lilly Kinsale Ltd. - March 16, 2018

Source: https://www.keypedia.com/records/483/eli-lilly-kinsale-ltd/57ad931f-35e2-41dd-a9b8-31c2d27e745c

> FDA 483 for Eli Lilly Kinsale Ltd. on March 16, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eli Lilly Kinsale Ltd.
- Inspection Date: 2018-03-16
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection was conducted at Eli Lilly Kinsale Limited, a drug substance manufacturer located in Kinsale, County Cork, Ireland, from March 12-16, 2018. The inspection identified three key observations detailed in a Form FDA 483, indicating areas requiring corrective action under the regulatory framework for drug manufacturing.The primary issue involved inadequate control to prevent microbial contamination in the drug substance manufacturing process. Persistent bioburden excursions and atypical results were noted in 2016 and 2017 campaigns, with several instances surpassing established in-process action limits, raising concerns about product integrity.Additionally, the company's data was found to be insufficient to definitively conclude that low-level bioburden excursions in its chromatography processes had no adverse impact on product quality. A specific product quality attribute's rate of change appeared inconsistent with historical data, preventing a conclusive assessment.Lastly, a procedural deficiency was identified in the firm's clarity testing method. The method did not meet European Pharmacopeia requirements, as the lowest standard used for testing fell outside the typical range of results observed for tested batches.Eli Lilly Kinsale Limited is required to address these observations by implementing comprehensive corrective actions to ensure compliance with quality and manufacturing standards.

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