FDA WARNING_LETTER - Old Fashioned Foods, Inc. - May 04, 2012

On August 16, 2012, the FDA issued a Warning Letter to Old Fashioned Foods, Inc. following an inspection from April to May 2012 of their low-acid and acidified food manufacturing and warehouse facilities in Mayville, Wisconsin. The inspection revealed significant deviations from Low-Acid Canned Foods regulations (21 CFR 113) and Acidified Foods regulations (21 CFR 114).

Key violations include: * **Failure to file scheduled processes:** The firm did not provide FDA with scheduled processes for various low-acid foods (e.g., cheese melt, cheese spread, pet treats), a repeat observation. * **Lack of qualified process authority:** Scheduled processes for low-acid cheese sticks and aerosol pet food products were not established by a qualified person. Similarly, acidified Jalapeno Bean Dip and Zesty Bean Dip lacked evaluation by a process authority. * **Failure to update filed processes:** Changes to the Salsa Con Queso scheduled process (higher cook times/temperatures) were not filed with FDA. * **Non-conformity to scheduled processes:** The firm failed to process products like processed cream cheese and cheese topping according to filed critical factors (e.g., no (b)(4) testing, incorrect (b)(4) range). * **Inadequate record review:** Processing records from September 2011 to April 2012