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

Source: https://www.keypedia.com/records/483/blue-bell-creameries-inc-lp/61c5663b-a0a8-41ba-8407-a07b533c4365

> FDA 483 for Blue Bell Creameries Inc L.P on April 30, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blue Bell Creameries Inc L.P
- Inspection Date: 2015-04-30
- Product Type: Devices
- Office Name: New Orleans District Office
- Summary: 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

## Related Documents

- [483 - 2015-04-30](https://www.keypedia.com/records/483/blue-bell-creameries-inc-lp/de68392a-256e-47d5-9d7a-679eb51d5817)
- [483_RESPONSE - 2015-04-30](https://www.keypedia.com/records/483_response/blue-bell-creameries-inc-lp/6aa648a8-87f7-49bf-bd06-389c51a356fa)

Company: https://www.keypedia.com/companies/blue-bell-creameries-inc-lp/37ca9c4e-66f5-4480-905f-08175c91fa5a

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea