# FDA 483 - Medisca, Inc. - November 20, 2025

Source: https://www.keypedia.com/records/483/medisca-inc/cdf0c117-ea4a-4cca-a5cd-b9c25614f129

> FDA 483 for Medisca, Inc. on November 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medisca, Inc.
- Inspection Date: 2025-11-20
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Medisca, Inc. in Plattsburgh, NY, a drug substance repacker/relabeler, revealed seven significant observations. These findings primarily concern inadequate calibration and cleaning procedures for hazardous drug repackaging equipment, inappropriate personnel gowning, and failures in preventing contamination during material handling. Additionally, the firm lacked proper component testing for excipients, failed to validate and document container closure integrity, and maintained production environments with contamination risks.

## Related Officers

- [Armen H. Youssoufian](https://www.keypedia.com/people/armen-h-youssoufian/47aa0283-ca67-4aec-8ac1-7d4cb222eb04)
- [Ogechi C. Nna, Investigator](https://www.keypedia.com/people/ogechi-c-nna-investigator/48aab041-6b37-47db-ab9c-71b85eeb24b7)
- [Ogechi C. Nna](https://www.keypedia.com/people/ogechi-c-nna/59452184-8197-4ba6-bf1d-78a7e003ef2c)
- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)
- [Edmund F. Mrak Jr., Investigator](https://www.keypedia.com/people/edmund-f-mrak-jr-investigator/a703158e-4c1d-4958-a988-4ac3416af4b3)

Company: https://www.keypedia.com/companies/medisca-inc/29e5455c-2007-4dea-a97f-b48ab31f0ac4

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d