# FDA 483 - Veltek Associates, Inc. - November 14, 2018

Source: https://www.globalkeysolutions.net/records/483/veltek-associates-inc/7eb8c84e-c19e-4284-9efc-cce5b108ba3a

> FDA 483 for Veltek Associates, Inc. on November 14, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Veltek Associates, Inc.
- Inspection Date: 2018-11-14
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Veltek Associates, Inc., a drug product packager in Malvern, PA, was cited for significant deficiencies during an FDA inspection. Observations included a lack of qualification for packaging equipment and inadequate preventative maintenance. Additionally, the firm failed to implement appropriate controls over computerized laboratory systems, allowing unauthorized data deletion, and lacked annual product review procedures for Decon-Hand.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/craig-d-zagata/1e9614e4-4efe-4d11-8b85-9fd43b64d40c)

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