FDA WARNING_LETTER - Michael Zakany LLC - March 03, 2015

On July 28, 2015, the FDA issued a Warning Letter to Michael Zakany LLC, dba Jose Madrid Salsa, following an inspection from February 20 to March 3, 2015. The inspection revealed serious violations of Acidified Food regulations (21 CFR Parts 108 and 114) and current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110). The firm manufactures acidified foods and is subject to these regulations.

Key violations include: 1. **Acidified Foods Violations:** * Failure to process acidified foods in conformity with scheduled processes (e.g., pH deviations in Black Bean Corn Poblano Salsa, use of incorrect acidifying agent). * Lack of supervision by a person who completed an approved Better Process Control School. * Failure to adequately test and examine containers for leakage and contamination (only visual checks performed). * Failure to maintain records of initial distribution of finished products, hindering recall effectiveness. * Failure to maintain records of examination of raw materials, packaging materials, or supplier guarantees. * Absence of current written procedures for product recalls.

2. **Current Good Manufacturing Practices Violations:** * Employees not washing and sanitizing hands thoroughly (e.g., licking salsa off hand and continuing to cap jars). * Failure to take precautions to