# FDA 483 - Lilly del Caribe, Inc - September 21, 2018

Source: https://www.keypedia.com/records/483/lilly-del-caribe-inc/ce0b5072-f84a-409e-b147-2a40ff94b035

> FDA 483 for Lilly del Caribe, Inc on September 21, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lilly del Caribe, Inc
- Inspection Date: 2018-09-21
- 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 five observations related to significant deficiencies in their quality control, complaint handling, and manufacturing investigation systems. The observations highlight issues with incomplete laboratory records, unrecorded deviations, inadequate complaint investigations, insufficient documentation of manufacturing discrepancies, and deficient in-process material inspection procedures. These findings indicate a need for improved data integrity, procedural adherence, and comprehensive record-keeping across several critical areas.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

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