# FDA 483 - Artesanales P.R. LLC - October 23, 2023

Source: https://www.keypedia.com/records/483/artesanales-pr-llc/c688b633-7752-48db-8aac-82569a1bdb83

> FDA 483 for Artesanales P.R. LLC on October 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Artesanales P.R. LLC
- Inspection Date: 2023-10-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Artesanales P.R. LLC, a drug manufacturer in Bayamon, PR, was cited for significant deficiencies in its quality system and production controls. The inspection revealed a complete absence of a quality control unit, inadequate validation and stability programs, and failures in raw material identity testing. Additionally, the firm failed to investigate out-of-specification results and lacked proper documentation practices for batch records and yield calculations.

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## Related Officers

- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

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

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