FDA 483 - Lusomedicamenta Sociedade Tecnica Farmaceutica S.A - September 27, 2019

During an inspection conducted from September 23-27, 2019, the U.S. Food and Drug Administration (FDA) identified significant deviations at Lusomedicamenta Sociedade Tecnica Farmaceutica S.A. These findings, issued as an FDA Form 483 pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlight multiple areas where the firm’s operations did not meet regulatory expectations for Good Manufacturing Practices.

Key observations included deficiencies in the calibration of instruments, where balances and scales used in critical production and dispensing areas lacked proper use range verification, despite established procedures. The inspection also noted inadequate sampling procedures for incoming raw materials, with samples not being taken from the top, middle, and bottom of containers, potentially compromising material quality control.

Furthermore, the firm failed to adhere to its own production and process control procedures, specifically by implementing a planned deviation in a filling line without proper change control approval or conducting necessary stability studies. Significant changes to validated processes, such as the removal of equipment from a filling line, were made without prior review and approval by the quality control unit or communication with the client. Lastly, the firm's data backup plan was not adequately followed, leading to a failure in regularly restoring and verifying data for critical systems, thereby risking data integrity.

Lusomedicamenta is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with quality system regulations and prevent recurrence.