# FDA 483 - Lilly del Caribe, Inc. - February 17, 2023

Source: https://www.keypedia.com/records/483/lilly-del-caribe-inc/0077c94c-6068-4f48-9c88-b92150dd9273

> FDA 483 for Lilly del Caribe, Inc. on February 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lilly del Caribe, Inc.
- Inspection Date: 2023-02-17
- 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, revealed two significant observations regarding quality unit failures. The firm failed to thoroughly investigate a microbial contamination discrepancy in a drug substance batch, leading to insufficient corrective actions. Additionally, the quality unit did not properly review and approve batch records and quality-related documents, resulting in manufacturing issues due to unapproved and untrailed procedural changes.

## Related Officers

- [Marian E. Ramirez - Investigator](https://www.keypedia.com/people/marian-e-ramirez-investigator/6534a00a-15b5-428e-8a89-4f4fbace702e)
- [Jose F. Velez - Investigator](https://www.keypedia.com/people/jose-f-velez-investigator/9f5cbbdc-60b9-4b73-a594-5591a90db77c)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/lilly-del-caribe-inc/7961ecde-19e4-4ccc-9701-c1979bc57aaa

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