# FDA 483 - AIAC International Pharma, LLC - November 07, 2025

Source: https://www.globalkeysolutions.net/records/483/aiac-international-pharma-llc/5eb35b8d-25d4-41c7-bf6f-45b9f9981b71

> FDA 483 for AIAC International Pharma, LLC on November 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AIAC International Pharma, LLC
- Inspection Date: 2025-11-07
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: AIAC International Pharma, LLC, a contract manufacturer in Arecibo, PR, was inspected from November 3-7, 2025. The inspection revealed a critical failure to establish adequate written procedures for production and process controls, specifically concerning the staging and tracking of materials during manufacturing operations. This deficiency resulted in inadequate material identification and control, leading to repeated incidents of incorrect material usage and demonstrating the ineffectiveness of prior corrective actions.

## Related Documents

- [483 - 2018-06-01](https://www.globalkeysolutions.net/records/483/aiac-international-pharma-llc/03bfa2c8-129d-423f-898b-eba4f0ee2c71)

## Related Officers

- [Yoriann M. Cabrera Bartolomei](https://www.globalkeysolutions.net/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [investigator](https://www.globalkeysolutions.net/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.globalkeysolutions.net/companies/aiac-international-pharma-llc/f2a0eb8d-93c0-4b7e-a46c-72f483b241c3

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