The latest FDA inspection of our plant in Celrà (Girona), Spain in September resulted in no “Form 483” (no observations were noted).
The inspection was carried out by an FDA investigator and covered cGMP and preapproval for several products.
For the Celrà site this was the fifth consecutive FDA inspection without any observation. Malta site inspection earlier this year was also a no ‘Form 483’ one. This is an excellent record particularly in the year of the 40th anniversary of the foundation of the company.