# FDA 483 - Veltek Associates, Inc. - February 06, 2025

Source: https://www.globalkeysolutions.net/records/483/veltek-associates-inc/d65437c6-d3ed-446c-8291-7c07afa4ba50

> FDA 483 for Veltek Associates, Inc. on February 06, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Veltek Associates, Inc.
- Inspection Date: 2025-02-06
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Veltek Associates, Inc. in Malvern, PA, a drug repacker/relabeler, identified a significant quality control issue. The firm failed to establish and document the accuracy, specificity, and reproducibility of analytical test methods used for releasing over-the-counter drug products. Specifically, the assay test for ethanol in DECON-HAND was not verified under actual testing conditions.

## Related Documents

- [483 - 2018-11-14](https://www.globalkeysolutions.net/records/483/veltek-associates-inc/7eb8c84e-c19e-4284-9efc-cce5b108ba3a)

## Related Officers

- [ Drug Investigator](https://www.globalkeysolutions.net/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

Company: https://www.globalkeysolutions.net/companies/veltek-associates-inc/78726ecd-c148-4749-9092-0e81d250cd5c

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8