Blue Bell Creameries Inc L.P – FDA 483, Apr 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