# FDA 483 - AIAC International Pharma, LLC - June 01, 2018

Source: https://www.globalkeysolutions.net/records/483/aiac-international-pharma-llc/03bfa2c8-129d-423f-898b-eba4f0ee2c71

> FDA 483 for AIAC International Pharma, LLC on June 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AIAC International Pharma, LLC
- Inspection Date: 2018-06-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: During an inspection from May 22 to June 1, 2018, Actac International Pharma, LLC in Arecibo, PR, a drug manufacturer, was cited for failing to follow written production and process control procedures and for inadequate documentation. This included incomplete laboratory logbook entries for lot approvals and a delayed notification to a supervisor regarding a power failure and humidity excursion that impacted an API batch.

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- [483 - 2025-11-07](https://www.globalkeysolutions.net/records/483/aiac-international-pharma-llc/5eb35b8d-25d4-41c7-bf6f-45b9f9981b71)

## Related Officers

- [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/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6