Ciresa Formaggi Snc – FDA Warning Letter, Jan 31, 2012

On July 9, 2012, the FDA issued a Warning Letter to Ciresa Formaggi, Snc. following an inspection of their cheese processing facility in Introbio, Italy, on January 30-31, 2012. The inspection revealed serious deviations from Current Good Manufacturing Practice (CGMP) regulations for foods (21 CFR Part 110), specifically regarding insanitary conditions.

The primary violation identified was the firm's use of (b)(4) for aging cheese, including Taleggio D.O.P., that are not composed of smooth, cleanable surfaces. These (b)(4) were observed to have rough areas and splintered (b)(4), preventing adequate cleaning and sanitizing, a violation of 21 CFR Part 110.40(a). Although cheese was placed on cotton cloths, the investigator observed direct contact between the cheese sides and the unsanitary (b)(4) surfaces.

The FDA deemed the firm's February 21, 2012, response to the FDA-483 inadequate. The proposed corrective action of using larger cloths was rejected as it does not enable adequate cleaning and sanitizing, and the porous cloths could allow organic matter and bacteria to penetrate.

Consequently, the Taleggio D.O.P. cheese is considered adulterated under Section 402(a)(4) of the