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:
- Management Controls
- Design Controls
- 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.
HOW TO CHECK THE RESULT OF THE FDA ALCHIMIA AUDIT
The result of the Alchimia’s FDA audit of last February is available online by accessing the Inspection Classification Database made available by the FDA.
It is possible to start the search, entering Al. Chi. Mi. A. Srl (with spaces in between) in the Firm Name field.
After starting the search by clicking the “SEARCH” button at the end of the page, the database will show the Alchimia Inspection classification as “NAI”, which means no action indicated.