The inspection revealed that the firm had not formally amended its approved licenses to reflect manufacturing changes. Page 2, T92-47, Sclavo Italy. FDA's review of Biocine Sclavo's production facilities and processes is continuing. The firm is cooperating with FDA in this matter. Biocine Sclavo manufactures bacterial vaccines, including a variety of combinations of diphtheria and tetanus toxoids and tuberculin skin tests.
All products are also available from other licensed firms.