# FDA 483 - Lilly del Caribe, Inc - July 23, 2013

Source: https://www.keypedia.com/records/483/lilly-del-caribe-inc/0c58a251-c690-4739-9d0d-2098e0f0ec8e

> FDA 483 for Lilly del Caribe, Inc on July 23, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lilly del Caribe, Inc
- Inspection Date: 2013-07-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Lilly del Caribe, Inc. in Carolina, PR, was inspected and received a Form 483 with four observations. The inspection revealed significant issues including inadequate investigations into consumer complaints about capsule defects, failure to submit required field alert reports, and a quality control unit that did not properly manage nonconforming materials. Additionally, the facility suffered from recurring microbial contamination in manufacturing areas due to environmental control deficiencies.

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## Related Officers

- [Libia Lugo](https://www.keypedia.com/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)
- [Investigator ](https://www.keypedia.com/people/raquel-gonzalez-rivera/84cdd41f-b03c-4d13-a289-e2ebf4417c3c)

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