Inspections, Compliance, Enforcement, and Criminal Investigations
UltraFoods, Inc. 18-Aug-05
Department of Health and Human Services
Public Health Service
555 Winderley PL, Ste. 200
August 18, 2005
Mr. Charles Adam
Chief Executive Officer
5827 17th Street, East
Bradenton, FL 34203
Dear Mr. Adam:
On March 14-15, 2005, we inspected your seafood processing facility, located at the above address. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123) and Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (GMP) regulation, Part 110 (21 CFR 110). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the 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-eat seafood spreads and dips are adulterated in that these products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the seafood HACCP regulation through links in FDA's homepage at http://www.fda.gov.
The deviations, observed during the inspection and upon further examination of the documents collected during that inspection, are as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a seafood HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR Part 123.3(f) as "any biological, chemical, or physical property that may cause food to be unsafe for human consumption".
However, your firm's seafood HACCP plans for Smoked Fish Spread (King Fish - Whiting) and Shrimp & Cheese Spread do not list the biological food safety hazard of pathogen growth and toxin formation as a result of time and temperature abuse. Controls for pathogen growth/toxin formation for these products may include a thawing critical control point (CCP) if the fish products used in your final spreads are received by your firm frozen; or a receiving CCP for the fish products if received by your firm refrigerated or under ice (or cooling media). In addition, because these are high risk, ready-to-eat products, FDA recommends a final refrigerated storage CCP for monitoring proper refrigerated temperatures to prevent pathogen growth/toxin formation as a result of potential time/temperature abuse during refrigerated storage.
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a seafood HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point (CCP) is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels".
However, your firm's seafood HACCP plans for Salmon Cheese Spread, Shrimp-Cheese Spread and Smoked Fish Spread (Tuna and Mahi-Mahi) do not list a CCP for refrigerated storage to control the biological food safety hazard of pathogen growth/toxin formation due to time/temperature abuse and to additionally control the chemical food safety hazard of histamine formation in your scombroid species, (i.e., Tuna and Mahi Mahi) for your Smoked Fish Spread (Tuna and Mahi-Mahi).
Additionally, your HACCP plan for Smoked Fish Spread (Tuna and Mahi Mahi) does not include a cooling CCP to control the biological food safety hazard of pathogen growth/toxin formation due to time and temperature abuse.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR Part 123.6(c)(4).
However, your firm's HACCP plan for Smoked Fish Spread (Tuna and Mahi Mahi) lists a monitoring frequency as "every hour" at the cooking CCP that is not adequate to monitor the critical limit for this CCP. The critical time limit listed for the cooking process is 30 minutes; consequently, monitoring the cooking time every hour will result in monitoring of only every other batch. FDA recommends continuous monitoring of every batch to ensure that the scheduled cook time and temperature combination is successfully achieved.
Moreover, FDA recommends that, when monitoring cooking temperatures, you monitor the temperature of the cooking equipment, as opposed to the temperature of the product (i.e., internal temperature) for the duration of the cook cycle.
In addition your HACCP plans for Smoked Fish Spread (Tuna and Mahi Mahi) and Salmon and Cheese Spread list monitoring procedures at the cooking CCP that are do not ensure that the critical limits have been adequately met. Your respective plans list that monitoring will be accomplished with "visual thermometer" and "digital thermometer." Neither method (i.e., thermometers) is capable of continuously recording the temperature to ensure that a temperature of 160°F is maintained for the duration of the entire 30 minute cook cycle, as listed in your plan. We recommend that firms use temperature recording equipment capable of continuously monitoring temperature during the entire cooking cycle.
4 . You must implement the monitoring procedures that you have listed in your seafood HACCP plan, to comply with 21 CFR 123 .6(b). However, your firm did not follow the monitoring procedure of "cool to Internal Temp of 40° within 2 hrs." at the cooling CCP to control pathogen growth/toxin formation due to time/temperature abuse as listed in your seafood HACCP plan for Salmon Cheese Spread. During our inspection on 3/15/05, our investigator reported that record reviews revealed that you did not record internal temperatures of the salmon during the cooling step.
5. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123 .11(b). However, your firm did not monitor conditions and cleanliness of food contact surfaces with sufficient, frequency to ensure control as observed by our investigator during the processing of crab and cheese dip on 3/15/05. Our investigator also observed employees on 3/15/05 using scoops, spatulas, and other small utensils (that are considered food contact surfaces for processing of your food products), from the washing room without sanitizing them before use.
6. You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c) . However, your firm did not maintain sanitation monitoring records for two (2) of the eight (8) areas of sanitation required for the processing of high-risk, ready-to-eat seafood spreads and dips as observed by reviewing sanitation records collected by our investigator during the March 2005 inspection. Sanitation check records dated [redacted] and [redacted] failed to include: protection from adulterants; and labeling, storage, and use of toxic compounds. Additionally, on all of these dates, excluding [redacted] unsatisfactory monitoring procedures were documented; however, no corrective actions were documented indicating that these problems were corrected.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations, and the Current Good Manufacturing Practice regulations for human food (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please notify this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct these violations including an explanation of each step taken to prevent their reoccurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason or the delay and the time frame within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Diane J. Englund, Compliance Officer, 555 Winderiey Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issue in this letter, please contact Ms. Englund at (407) 475-4741.
Emma R. Singleton
Director, Florida District