FDA 483 - Blue Bell Creameries Inc L.P - April 30, 2015

This FDA Form 483 response from Blue Bell Creameries, Inc. for their Sylacauga, Alabama facility, dated May 22, 2015, addresses observations from an inspection conducted April 6-30, 2015. Blue Bell voluntarily ceased production at all facilities, including Sylacauga, on April 20, 2015, to conduct a comprehensive review and implement corrective actions.

Key observations and their responses include:

1. **Failure to perform microbial testing:** Blue Bell is developing a revised environmental testing program, including routine and enhanced test-and-hold procedures for *Listeria monocytogenes* (Lm) and indicator organisms. This involves testing finished product and food contact surfaces, with presumptive positives triggering product destruction and line shutdown for investigation, cleaning, and sanitization. 2. **Unsuitable outer garments:** A comprehensive revision of Good Manufacturing Practices (GMPs) is underway, including detailed employee training on hygiene and minimizing contact with equipment. A company-wide clothing policy will be instituted, providing company-issued coverings and implementing a captive footwear policy. 3. **Failure to maintain food contact surfaces:** Employees will be retrained on proper hygiene, specifically not extending unclean hands or clothing over product or food-contact surfaces. GMPs are being updated to reinforce this. 4. **Employees not washing/sanitizing hands thoroughly:** Employees will be retrained on handwashing