# FDA WARNING_LETTER - Bumblefish KC LLC - August 27, 2013

Source: https://www.keypedia.com/records/warning_letter/bumblefish-kc-llc/6a7cb0d5-1267-44de-8841-3f08b935f656

> FDA WARNING_LETTER for Bumblefish KC LLC on August 27, 2013. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bumblefish KC LLC
- Inspection Date: 2013-08-27
- Product Type: Food
- Office Name: Kansas City District Office
- Summary: On August 25-27, 2013, the FDA inspected Bumblefish K.C. LLC's seafood processing facility at 4120 Pennsylvania Avenue Suite 10, Kansas City, MO 64111. The inspection revealed serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their ready-to-eat sushi products, including all-natural Salmon Roll, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Significant violations include:
1.  Failure to adequately control *Clostridium botulinum* in sushi roll products by not cutting open vacuum-packed fish containers during thawing, violating 21 CFR 123.6(b).
2.  Failure to properly calibrate process monitoring equipment (thermometers and pH meter probe), violating 21 CFR 123.8(a)(2)(ii).
3.  Failure to maintain sanitation monitoring records, violating 21 CFR 123.11(c).
4.  Failure to monitor sanitation conditions and practices with sufficient frequency, with observed instances of employees not wearing hair restraints, unsanitary equipment, and an unsanitary ice machine, violating 21 CFR 123.11(b).
5.  Failure to

## Related Officers

- [District Director](https://www.keypedia.com/people/john-w-thorsky/7a765cf2-aafc-48f7-98f5-172795a7d0d8)

Company: https://www.keypedia.com/companies/bumblefish-kc-llc/264ed19a-8c5b-44d1-b6ec-01b2df5042d9

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79