FDA 483 - Contec Inc- Sporicidin Division - November 13, 2015

An FDA inspection of Contec Inc- Sporicidin Division in Spartanburg, SC, a specification developer, revealed significant deficiencies in its quality system. The firm failed to perform quality audits at defined intervals and in accordance with established procedures. Additionally, the results and dates of management reviews were not properly documented, and the CEO did not participate in a required review.