# FDA 483 - Buchler Gmbh - August 12, 2019

Source: https://www.keypedia.com/records/483/buchler-gmbh/3ffc2f6d-aaee-44f0-ae47-512d8d2eeb78

> FDA 483 for Buchler Gmbh on August 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Buchler Gmbh
- Inspection Date: 2019-08-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Buchler Gmbh, an API manufacturer in D-3810 Bruanschweig, DE, revealed significant deficiencies in their quality systems. Observations included inadequate validation of computer systems for data protection and backup, insufficient cleaning validation protocols, and a lack of stability data for all product containers sold to the market. These issues indicate a need for improved data integrity, validation practices, and quality control.

## Related Officers

- [CO CDER OMQ](https://www.keypedia.com/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

Company: https://www.keypedia.com/companies/buchler-gmbh/c56c14cb-6767-4b1e-8bec-374365e2340a

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1