# Holopack Verpackungstechnik GmbH – FDA 483, Feb 18, 2020

Source: https://www.keypedia.com/records/483/holopack-verpackungstechnik-gmbh/7299bab1-90b9-4c9f-ba89-166d8f915489

> FDA 483 for Holopack Verpackungstechnik GmbH on February 18, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Holopack Verpackungstechnik GmbH
- Inspection Date: 2020-02-18
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Holopack Verpackungstechnik GmbH, a drug manufacturer in Sulzbach-Laufen, Germany, revealed significant deficiencies in their sterile drug product manufacturing processes. Observations included inadequate validation of sterile processes, issues with equipment calibration and qualification, and scientifically unsound water sampling plans for bioburden testing. These findings indicate a lack of robust controls to ensure product quality and sterility.

## Related Documents

- [483 - 2020-02-18](https://www.keypedia.com/records/483/holopack-verpackungstechnik-gmbh/84ad0687-81c8-420e-8195-a7636b43f850) — date: February 18, 2020

## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.keypedia.com/companies/holopack-verpackungstechnik-gmbh/3e96b02f-23a1-4178-bf40-2e389739e0b0

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4