# FDA 483 - FillTech USA, LLC - April 14, 2022

Source: https://www.keypedia.com/records/483/filltech-usa-llc/ac5d69c5-d8f0-42bf-917a-6b035e432c60

> FDA 483 for FillTech USA, LLC on April 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FillTech USA, LLC
- Inspection Date: 2022-04-14
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Filltech USA, LLC in Rockwell, NC, revealed significant deficiencies in equipment qualification, computer system controls, and raw material storage conditions. The firm failed to qualify a filling line and validate its water system, allowed test data deletion from its FTIR system, and lacked temperature/humidity mapping for raw material storage. These issues indicate a lack of appropriate controls to ensure drug product quality and purity.

## Related Documents

- [483 - 2025-12-19](https://www.keypedia.com/records/483/filltech-usa-llc/9f5f691a-2663-457b-aeb4-637a4eef0113)

## Related Officers

- [Owner/Inspector](https://www.keypedia.com/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)
- [issuing_officer](https://www.keypedia.com/people/harshal-j-desai/9ccefb1f-95fc-4a17-9647-eecb5c3ce838)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/filltech-usa-llc/dfe3278f-cccc-47fa-813c-d3b3fdee2da2

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7