FDA WARNING_LETTER - Bay Island, Inc. - August 02, 2010

The FDA conducted an inspection of Bay Island, Inc.'s packaged food warehouse in Burnsville, Minnesota, on multiple dates in July and August 2010, revealing serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110. These deficiencies render the firm's food products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Key violations include the failure to implement effective measures to exclude pests and protect food from contamination, as required by 21 CFR 110.35(c). Investigators observed extensive evidence of rodent activity, such as gnawed product packages, numerous rodent excreta pellets, dead mice, and fluorescent stains indicating rodent urine. The firm also admitted to not having pest control services from January to July 2010. Additionally, the facility lacked adequate screening or other pest protection, violating 21 CFR 110.20(b)(7), with multiple dock doors left open without screens, worn brush plates, and open doorways to an adjoining warehouse. The firm also failed to update its facility registration information, specifically the address, within 60 days of change, as mandated by 21 CFR 1.234, despite operating at the current location since June 2009. While some corrective discussions and initial pest control actions were noted during the inspection, the firm's written response lacked documentation of comprehensive corrections. Bay Island, Inc. is required to provide a written response within 15 working days detailing corrective actions, including documentation from licensed exterminators, pest control plans, and photographs of improvements. Failure to implement lasting corrections could lead to FDA enforcement actions, such as product seizure or injunction.