# FDA 483 - Allessa GmbH - August 09, 2019

Source: https://www.keypedia.com/records/483/allessa-gmbh/160596b2-8be7-4c53-a1d8-78ab4113bd9d

> FDA 483 for Allessa GmbH on August 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allessa GmbH
- Inspection Date: 2019-08-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Allessa GmbH, an API manufacturer in Frankfurt am Main, Germany, received a Form 483 with seven observations highlighting significant deficiencies in their quality systems. The inspection revealed a lack of computer system validation, absence of process and cleaning validations, and inadequate equipment qualification and calibration. Additionally, the firm failed to maintain calibration records, did not adhere to quality agreement responsibilities for stability and process validation, and lacked a written long-term stability program for their API.

## Related Officers

- [Yumi Hiramine](https://www.keypedia.com/people/yumi-hiramine/26c5059f-8f61-42cf-ae79-65a7b942d2c7)

Company: https://www.keypedia.com/companies/allessa-gmbh/e9de5be2-7014-4436-98fd-18e7ec4fd1b1

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