Louie Foods International FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

• FDA laboratory analysis of environmental sample number 950546 collected on February 15, 2017, confirmed that two (2) environmental subsample swabs collected from the floor and the drain in your cooler were positive forListeria monocytogenes (L. monocytogenes)a human pathogen.  We recommend that you take steps to monitor and controlL. monocytogenesin the environment to prevent it from getting into your finished foods.

Please respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific actions you are taking to correct these violations and prevent their recurrence.  More specifically, your response should include documentation of the corrections and/or corrective actions your firm has taken.  If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.

1Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117)(PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. Seehttp://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Datesfor PC rule compliance dates.

Potential Health Risks

The Food and Drug Administration (FDA) conducted an inspection of your sprout operation and food processing facility, located at 471 South Teilman Avenue, Fresno, California, from February 13 through February 28, 2017.  The inspection revealed that your alfalfa and mung bean sprouts are adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act) in that they have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.  In addition, the inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110)1.  These condi

Regulatory Context

This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your March 21, 2017 response that describes corrective actions you took or will take.  However, we are unable to evaluate the adequacy of your response because you did not include documentation, such as records or photos, as evidence of your compliance. We intend to verify the adequacy of your corrective action at a future inspection.Insanitary Conditions and Practices in the Sprout Operation

Our investigators observed the following conditions and practices at your firm during the processing of sprouts:

2. The bins containing mung bean sprouts were stacked one on top of another so that sprouts were in direct contact with the bottom of another bin.  Directly prior to stacking, the bottoms of the bins were observed coming into contact with a black plastic pallet that was soiled with dirty water and old wet mung bean seeds.