# FDA 483 - Jeni's Splendid Ice Creams, LLC - April 30, 2015

Source: https://www.keypedia.com/records/483/jenis-splendid-ice-creams-llc/eb8eee1f-7367-4614-a7e7-1be57f905a2a

> FDA 483 for Jeni's Splendid Ice Creams, LLC on April 30, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jeni's Splendid Ice Creams, LLC
- Inspection Date: 2015-04-30
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of a facility manufacturing frozen ready-to-eat ice cream, yogurt, and sorbet revealed multiple violations of current good manufacturing practices.

Key issues include:
- **Personnel Competency and Responsibility:** The Regulatory Manager and Director of Operations demonstrated a lack of competency by failing to institute environmental sampling/testing, being unaware of inadequate sanitation of batch freezers and sanitizing wipes, not knowing the need for floor sanitization, and permitting uncontrolled gardening by employees.
- **Microbial Testing:** No environmental monitoring or finished product testing program was in place, despite manufacturing ready-to-eat products.
- **Facility Space and Layout:** Insufficient space in prep and production rooms led to employee and equipment traffic congestion, and poor placement of sinks relative to open product.
- **Sanitation and Maintenance:** Floors were not sanitized, spilled product was observed, and there were no door foamers to prevent cross-contamination. Dark residue was found on power outlets, light covers, and air returns. Dust and dirt were on fire sprinklers and hose reels. Discolored plastic strip curtains were noted.
- **Equipment Design and Cleanliness:** Non-food-contact equipment (piston filler insulation) was not easily cleanable, with product leaks and residue. Batch freezers had unsealed holes and uncovered knob stems with adhering material, hindering proper cleaning.
- **Raw Material Storage:** Ingredients like cocoa powder, sugar, and flour were stored directly beneath sinks used for washing raw

## Related Documents

- [483_RESPONSE - 2015-04-30](https://www.keypedia.com/records/483_response/jenis-splendid-ice-creams-llc/a3f1c66e-f46f-48c4-89d2-5e47668f7b04)

## Related Officers

- [Craig P. Seaborn](https://www.keypedia.com/people/craig-p-seaborn/730fc254-fcc3-42a0-803d-0c0cb1436b82)
- [Investigator ](https://www.keypedia.com/people/darren-s-morgan/bfb63e75-eaae-4afb-9d80-e1da673efade)

Company: https://www.keypedia.com/companies/jenis-splendid-ice-creams-llc/fccc9053-f200-4392-bff4-c438e4303d2c

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22