From 4 to 7 February Alchimia srl, as a manufacturer of Medical Devices, hosted the US Food and Drug Administration (FDA) government agency for a Level II QSIT audit, all four major subsystems were covered:
Corrective and Preventive Actions (CAPA)
Manufacturing & Process controls.
NO major observations(FDA 483) were raised, as shown in the Establishment Inspection Report (EIR).
This result demonstrates the compliance of Alchimia srl to Good Manufacturing Practices (GMP).
The FDA approval adds to the quality system certifications, ISO 9001 and ISO 13485, and to the authorizations already issued by national and international regulatory bodies following on-site audits.
Alchimia is one of the leading European manufacturers of medical devices for ophthalmic surgery and human tissue banking with the aim of improving the daily routine of the medical personnel and the quality of life of patients.
Ok, I Agree