Inspections, Compliance, Enforcement, and Criminal Investigations
Family Fresh Pack, LLC 5/19/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
- You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a 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 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads does not list the food safety hazards of allergens, Clostridium botulinum and food intolerance substances. FDA recommends that controls for allergens and food intolerances (i.e., sulfite sensitivity) be controlled through a review of the ingredients on the finished product labels to ensure that allergens and any substances that cause food intolerances are accurately documented on the labels. Additionally, your firm is packaging the products in containers that are oxygen impermeable and thus create conditions conducive to Clostridium botulinum growth and toxin formation.
- You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads lists a critical limit, temperature (b)(4), that is not adequate to control pathogens. The temperature ranges you have listed as critical limits for storage may result in your product being held at temperatures that support pathogen growth for extended periods of time. We recommend continuously maintaining storage temperatures at or below 38°F.
- You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at (b)(4) critical control point to control pathogens listed in your HACCP plan for Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads. Specifically, the following were observed:
- During the inspection noted above, you did not have monitoring records that document control of sulfites in your frozen shrimp product since the previous FDA inspection dated January 21, 2010. At that time, you did not have temperature recording charts for your seafood cooler from February 8 through November 15, 2010. However, you manufactured and stored seafood in this cooler on a regular basis during that time.
- You were storing Crab Creole cold pack cheese in Cooler #1. This cooler did not have a temperature recording device.
- On December 20, 2010, the temperature recording chart for the seafood cooler was blank because the pen was out of ink.
- You did not address the affected product that was stored in your seafood cooler and Cooler #1 when the coolers were not being monitored.
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with cGMP requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor protection of food, food packaging material, and food contact surfaces from adulteration with sufficient frequency to ensure compliance with the cGMP requirements in 21 CFR Part 110 as evidenced by:
- Employees were observed placing their fingers inside filled cheese cups while moving them to the check weighing scale without first washing and sanitizing their hands.
- You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing and sanitizing of toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions, and exclusion of pests required for the processing of Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads from January 21 – December 22, 2010.
- Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads at (b)(4) critical control point to control pathogens to include Clostridium botulinum is not appropriate. Specifically, the corrective action does not (b)(4).
- Spreadable Lobster Bisque: According to documents collected during the inspection of your firm, your product contains a lobster base. The lobster base is a multi-component product; however, your label fails to list all the components listed in the lobster base. For example:
- Butter (Sweet Cream, Salt)
- Spreadable Crab Creole: According to documents collected during the inspection of your firm, your product contains a crab base. The crab base is a multi-component product; however, your label fails to list all the components listed in the crab base. For example:
- Butter (cream, salt, lactic acid)
- Spreadable Shrimp Scampi: According to documents collected during the inspection of your firm, your product contains a shrimp base. The shrimp base is a multi-component product; however, your label fails to list all the components listed in the crab soup base. For example,
- Butter (cream, lactic acid)
- The “CONTAINS” statement on your Spreadable Lobster Bisque, Spreadable Crab Creole and Spreadable Shrimp Scampi products immediately follows the ingredient statement. Such a statement must be separate from the ingredient statement rather than immediately following the ingredient statement as to give the appearance of being included within the ingredient statement, 21 CFR 101.2(e).
- The “CONTAINS” statement on your Spreadable Lobster Bisque product does not include egg. Although egg is listed in the ingredient statement, if, in addition to listing the allergen source in your ingredient statement, you also use a “Contains” statement, all allergen sources must also be listed in the “Contains” statement.