FDA WARNING_LETTER - Well Luck Co. Inc. - August 07, 2014

An FDA inspection of Well Luck Company, Inc.'s food manufacturing and storage facility in Atlanta, GA, from July 23 to August 7, 2014, revealed serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110. These violations, detailed in a FORM FDA 483, render the products adulterated per Section 402(a)(4) of the FD&C Act due to insanitary conditions. Key deficiencies included widespread active rodent and insect activity, failure to exclude pests, and improper storage of equipment and waste creating pest harborage. The facility also failed to maintain buildings and fixtures in good repair, exhibiting significant gaps in doors and walls, and did not prevent drip and condensate from contaminating food. Additionally, there was inadequate screening against pests and a lack of barriers to protect food and packaging materials from contamination. The firm is required to respond in writing within fifteen working days, outlining corrective actions, timelines, and supporting documentation. Failure to promptly correct these violations may lead to regulatory actions such as product seizure, injunction, and re-inspection fees.