# FDA 483 - Lilly del Caribe, Inc - February 25, 2022

Source: https://www.keypedia.com/records/483/lilly-del-caribe-inc/46c27262-2d1c-43db-8d65-648ca4b97af0

> FDA 483 for Lilly del Caribe, Inc on February 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lilly del Caribe, Inc
- Inspection Date: 2022-02-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Lilly del Caribe, Inc. in Carolina, PR, a drug product manufacturer, revealed significant deficiencies in quality control laboratory practices. The firm failed to adequately investigate out-of-specification results, often invalidating them without confirmed root causes or extending investigations to other affected batches. Additionally, laboratory controls allowed for the manipulation of test parameters and recalculation of OOS results stemming from incorrect sample preparation, compromising data integrity.

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## Related Officers

- [Libia Lugo](https://www.keypedia.com/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.keypedia.com/companies/lilly-del-caribe-inc/5091d4cf-a496-46ba-96aa-da9dbb686073

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6