PROLAC, INC. – FDA Warning Letter, Sep 9, 2010

The FDA inspected Prolac Inc., a food manufacturing facility in Bayamon, Puerto Rico, from August 19 to September 9, 2010, identifying serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110, rendering products adulterated per Section 402(a)(4). Additionally, several "Queso Del Pais Tridas" products were found to be misbranded under Section 403. CGMP deficiencies included insanitary production procedures leading to contamination, inadequate employee hygiene, ineffective pest exclusion, unsanitary facility maintenance (e.g., damaged ceilings, standing water, leaks), inadequate plumbing (lacking backflow prevention), improper storage of cleaning compounds, and insufficient hot water for cleaning and handwashing. Labeling violations involved misbranding due to undeclared ingredients (21 CFR 101.4(a)(1)), false or misleading ingredient statements (Section 403(a)(1)), and improper nutrition facts formatting (21 CFR 101.9). Further labeling issues included failure to repeat all required information in both languages (21 CFR 101.15(c)), inclusion of intervening material in ingredient statements (21 CFR 101.2(e)), and a missing letter in a vitamin declaration. The letter noted a history of similar sanitation and labeling problems from prior 2007 and 2009 inspections, indicating a persistent lack of compliance. Prolac Inc. must take prompt corrective action and respond in writing within fifteen working days, providing documentation of implemented changes to avoid further regulatory action, such as seizure or injunction.