# FDA 483 - Vortech Pharmaceuticals Ltd - February 09, 2022

Source: https://www.keypedia.com/records/483/vortech-pharmaceuticals-ltd/21fa3025-4499-47eb-ac52-b34387c0d32d

> FDA 483 for Vortech Pharmaceuticals Ltd on February 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vortech Pharmaceuticals Ltd
- Inspection Date: 2022-02-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Vortech Pharmaceuticals Ltd, a drug manufacturer in Dearborn, MI, was cited for significant deficiencies in its quality control systems. The inspection revealed a lack of process validation for its only drug product, Fatal Plus Solution, and an absence of annual product reviews. Furthermore, the firm failed to conduct microbiological testing for its drug product and lacked scientifically justified water testing procedures.

## Related Documents

- [483 - 2024-11-06](https://www.keypedia.com/records/483/vortech-pharmaceuticals-ltd/d8237f2e-798f-4395-bb33-b37e6485c820)

## Related Officers

- [Courtney E. Hillier](https://www.keypedia.com/people/courtney-e-hillier/4bb6ba54-896a-4296-a4ea-81d8801fdc2f)
- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.keypedia.com/companies/vortech-pharmaceuticals-ltd/59ceb326-d3dc-40f7-974c-67e3d66c1b17

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0