Inspections, Compliance, Enforcement, and Criminal Investigations
Bumblefish KC LLC 9/20/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
September 20, 2013
RETURN RECEIPT REQUESTED
Ref. – KAN 2013-18
Mr. Paul Fred Scholla, Owner/Chief Financial Officer
Bumblefish K.C. LLC.
5621 Oak Street
Kansas City, MO 64113
Dear: Mr. Scholla:
We inspected your seafood processing facility, located at 4120 Pennsylvania Avenue Suite 10 Kansas City, MO 64111 on August 25-27, 2013. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. These deviations render the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your ready to east sushi products, including all-natural Salmon Roll, are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must have a HACCP plan that implements the monitoring, recordkeeping, and verification procedures listed in their HACCP plan as required by 21 CFR 123.6(b). However, you are not adequately controlling the hazard of Clostridium botulinum in your sushi roll products as you do not cut open vacuum packed containers of fish products while thawing.
2. You failed to properly calibrate process monitoring equipment, as required by 21 CFR 123.8(a)(2)(ii). You do not calibrate thermometers to verify accuracy and you do not store your pH meter probe appropriately to ensure accurate readings.
3. You must maintain sanitation control records that, at a minimum, document the monitoring and corrections set out in 21 CFR 123.11(b) to comply with 21 CFR 123.11(c). However your firm does not maintain any sanitation monitoring records.
4. You failed to monitor sanitation conditions and practices with sufficient frequency to assure compliance with good manufacturing practices (GMP’s) as required by 21 CFR 123.11(b). However, there were several instances noted of employees not wearing hair restraints, use of unsanitary equipment, and an unsanitary ice machine.
5. You failed to sign your HACCP plan, as required by 21 CFR 123.6(d). Investigators observed the HACCP plan for Acidified Sushi Rice which was not signed by appropriate personnel.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Your response should be sent to Patrick L. Wisor, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Drive Suite 205, Lenexa, Kansas 66214.
John W. Thorsky
Kansas City District Office