# FDA 483 - Integrated Commercialization Solutions LLC - July 15, 2019

Source: https://www.globalkeysolutions.net/records/483/integrated-commercialization-solutions-llc/924ad6f2-18c0-4fc9-a499-bda8b7b860b6

> FDA 483 for Integrated Commercialization Solutions LLC on July 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Integrated Commercialization Solutions LLC
- Inspection Date: 2019-07-15
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Integrated Commercialization Solutions LLC, a repacker/relabeler in Brooks, KY, was cited for significant deficiencies in its quality control unit and complaint handling processes. The inspection revealed a lack of written procedures and qualification for visual inspection of finished products, as well as inadequate investigation and timely resolution of non-conformances and customer complaints. These issues indicate a systemic failure to ensure product quality and compliance.

## Related Officers

- [Microbiologist ](https://www.globalkeysolutions.net/people/doan-t-nguyen/2b1112b4-01b8-4581-82f2-86cbe29c8857)

Company: https://www.globalkeysolutions.net/companies/integrated-commercialization-solutions-llc/b7dd91bd-7a7b-4ad0-b33b-cbbfbfb06b66

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22