FDA 483 - Allessa GmbH - August 09, 2019

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.