# FDA 483 - Tekweld Solutions Inc. - January 16, 2025

Source: https://www.keypedia.com/records/483/tekweld-solutions-inc/c4a85287-53e0-4e7c-a242-5b79f8d2527e

> FDA 483 for Tekweld Solutions Inc. on January 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tekweld Solutions Inc.
- Inspection Date: 2025-01-16
- Product Type: drugs
- Office Name: New York District Office
- Summary: Tekweld Solutions Inc. in Hauppauge, NY, a drug relabeler, received a Form 483 with three observations during an FDA inspection. The firm demonstrated significant deficiencies in establishing a supplier verification program for bulk drug products and performing adequate testing. Furthermore, the company lacked a formal quality control unit, a change management program, and sufficient GMP training, alongside failing to implement necessary temperature and humidity controls for drug product storage.

## Related Documents

- [483 - 2020-01-17](https://www.keypedia.com/records/483/tekweld-solutions-inc/5d96aab3-ea77-4070-ae3f-596f77a7d3d7)

## Related Officers

- [Stephenie M. Ortiz](https://www.keypedia.com/people/stephenie-m-ortiz/b0923b14-b153-4893-8eb2-f5e6b1fd2041)

Company: https://www.keypedia.com/companies/tekweld-solutions-inc/e6dba5dc-9646-48c6-b2ec-2db246ce1297

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