# FDA 483 - Artesanales P.R. LLC - January 22, 2025

Source: https://www.keypedia.com/records/483/artesanales-pr-llc/2d0a7135-bba8-4836-9596-9ea09b7ea3d4

> FDA 483 for Artesanales P.R. LLC on January 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Artesanales P.R. LLC
- Inspection Date: 2025-01-22
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: Artesanales P.R. LLC in Bayamon, PR, received a Form 483 following a January 2025 inspection, citing a severe and repeated failure to establish a functional quality control unit. The firm failed to implement corrective actions from a previous inspection, leading to the manufacture and distribution of drug products without required laboratory release testing. This indicates a critical lack of adherence to cGMP regulations.

## Related Documents

- [483 - 2023-10-23](https://www.keypedia.com/records/483/artesanales-pr-llc/792d814c-a8d8-4d55-856c-89ba8235932f)
- [483 - 2023-10-23](https://www.keypedia.com/records/483/artesanales-pr-llc/c688b633-7752-48db-8aac-82569a1bdb83)

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Christian F. Gomez Lugo](https://www.keypedia.com/people/christian-f-gomez-lugo/866e531a-6354-45b2-8e43-1dfc9d146caf)

Company: https://www.keypedia.com/companies/artesanales-pr-llc/0f009db9-0b57-4983-94fa-b929674aab83

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8