# FDA 483 - Brisas del Caribe, Corp. - January 23, 2026

Source: https://www.keypedia.com/records/483/brisas-del-caribe-corp/199821d8-ac03-434a-a202-a8864786c369

> FDA 483 for Brisas del Caribe, Corp. on January 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brisas del Caribe, Corp.
- Inspection Date: 2026-01-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Brisas Del Caribe Corp, a warehouse and distribution facility in Canovanas, PR, was cited for two significant deficiencies during an FDA inspection. Inspectors observed that drug products were not stored under appropriate temperature conditions due to a lack of monitoring and control in the warehouse. Additionally, the firm's distribution system was found to be deficient, as it could not readily track product lots for recall purposes, and its recall SOP was inadequate.

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.keypedia.com/companies/brisas-del-caribe-corp/5a5bc6ea-bb04-4b84-b413-06a1c2d83225

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