As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Van Nuys, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In a July 16 warning letter, the FDA described March 18, 2020, Foreign Supplier Verification Program (FSVP) inspection at Copoliva Inc.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Refined Rice Bran Oil, manufactured by (redacted)., located in (redacted)
- Grape Seed Oil, manufactured by (redacted), located in (redacted)
- Organic High Oleic Sunflower Oil, manufactured by (redacted), located in the (redacted).
The full warning letter can be viewed here.
Sugiyo USA Inc.
A food firm in California is on notice from the FDA for violations of the seafood HACCP regulation and discovery of Listeria in their facility.
In a July 15 warning letter, the FDA described a February 26-28, 2020 inspection at Sugiyo USA Inc.
The FDA’s inspection found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and resulted in the issuance of an FDA Form 483.
The FDA received and reviewed a response to a previous letter on April 3, 2020, and still have serious concerns.
Serious concerns and violations are as follows:
FDA laboratory analysis of environmental samples collected from the pre-pasteurization area during the production of ready-to-eat (RTE) surimi-based seafood analog products determined that (redacted) of (redacted) environmental swabs tested positive for L. monocytogenes. (redacted) of the positive swabs were collected from food-contact surfaces which included the conveyor belts; the red color spray nozzle; (redacted) roller; (redacted) machine; and the surimi paste cart prior to pasteurization. The (redacted) other positive swabs were found on areas (a (redacted) drain and the wheel of a cart) near food contact surfaces in their main processing room.
Additionally, the firm’s environmental testing records show their firm identified Listeria species in (redacted) locations (food-contact surfaces and areas directly adjacent to food-contact surfaces) between Dec. 12, 2019, and Feb. 18, 2020. However, their firm did not take and/or document adequate corrective action in response to these findings.
The FDA’s findings, along with their testing results, indicate that their firm is not implementing effective methods and controls to eliminate L. monocytogenes or minimize its presence on food and food-contact surfaces.
The firm’s response described the following corrective actions taken in response to FDA findings of L. monocytogenes in their facility: hold all products produced on Feb. 26 and 27, 2020; re-test finished product lots for L. monocytogenes; clean the production area; and re-test their production area. Their response also included testing results and a training record for microbiological testing. However, their response did not indicate that they conducted an investigation to identify the cause of the contamination (e.g., root cause analysis) and did not include a copy of their revised environmental monitoring procedure.
The FDA recommends their environmental monitoring procedure include the following actions:
- Identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring;
- Identify the timing and frequency for collecting and testing samples;
- Identify the laboratory that will be conducting the testing and identify the analytical method(s) that will be used; and
- Establish corrective action procedures they will implement when Listeria spp. or L. monocytogenes is found.
The firm’s response included its environmental testing results for Feb. 26, 2020, to Mar. 6, 2020, which show (redacted) positive samples for L. monocytogenes. These positive samples were listed as “(redacted),” “(redacted)” and two as “(redacted).” However, their response did not provide sufficient context regarding where these samples were collected, and the corrective actions they took in response.
Note that FDA has issued a Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods. When finalized, the draft guidance will represent FDA’s current thinking on this topic.
- The firm must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements. However, the firm did not monitor the following areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements:
- Prevention of cross-contamination from unsanitary objects to food, food packaging material, and other food contact surfaces as evidenced by:
- Water observed dripping from the exterior wall at the entrance of the individually quick frozen (IQF) freezer tunnel directly onto pasteurized, unwrapped, RTE Alaska Snow Leg surimi-based analog products and a conveyor belt which conveys these products. Their response stated that they will (redacted). Their response did not include a timeframe for when they expect to have and implement a (redacted) to address this issue.
- As a result of their sanitation activities using a high-pressure hose, (redacted) water was observed throughout the north end of the RTE processing area where pasteurized, unwrapped, RTE Alaska Snow Leg surimi-based analog products are processed. FDA investigators also observed production using equipment on which (redacted) water contacted food-contact surfaces such as conveyor belts, weighing equipment, a (redacted) table, and bagging equipment used to process pasteurized products. High-pressure hoses should not be used in processing areas due to the potential for cross-contamination through the (redacted) of pathogens. Their response did not address this issue.
iii. The walls of the RTE processing area had peeling paint and accumulation of apparent mold/mildew. Their response did not address this issue.
- The underside of the conveyor belt after the (redacted) table was heavily soiled. This belt conveys pasteurized, unwrapped, RTE frozen Alaska Snow Leg surimi-based analog products. Their response did not address this issue.
- The handle of a water hose nozzle was stored directly on a heavily soiled water pipe. Water from this nozzle was used for sanitation purposes and as a (redacted). Their response did not address this issue.
- The underside of a (redacted) water line was heavily soiled near the Alaska Snow Leg (redacted) green horizontal and vertical conveying belts. Their response did not address this issue.
- Protection of food from adulteration with sanitizing agents, as evidenced by the following:
FDA investigators measured water drops and detected approximately (redacted) parts per million (ppm) free chlorine dripping directly onto pasteurized, unwrapped, RTE Alaska Snow Leg surimi-based analog products as the product was conveyed and passed through the incline conveyor and (redacted) bagging area. The firm’s Quality Control Assistant Manager informed FDA investigators that (redacted) water sprays are applied to the (redacted) where (redacted) RTE products are conveyed to prevent pathogen introduction after pasteurization. Sanitizing solutions when used on food contact surfaces are not to exceed (redacted) ppm free chlorine and must be adequately drained from food contact surfaces before contact with food. Their response stated (redacted). Their response did not include a timeframe for when they expect to have and implement a (redacted) to prevent sanitizer from directly contacting food.
- The firm must have a HACCP plan that at a minimum, lists the critical limits that must be met. A critical limit is defined 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, the firm’s HACCP plan for pasteurized vacuum-packaged RTE surimi-based seafood analog products (sticks and shreds) is not adequate in that it lists a critical limit of “(redacted)’” at their “(redacted)” critical control point (CCP) for the hazard of “C. Botulinum & toxin formation during finished product storage”. Because their HACCP plan uses (redacted) and (redacted) as the control for Clostridium botulinum (C. botulinum) growth and toxin formation, they must have controls to ensure their products are immediately and rapidly cooled and frozen after vacuum packaging and pasteurization. Nonproteolytic C. botulinum can grow at a minimum temperature of 38°F and will grow rapidly when temperatures exceed 70°F. However, FDA investigators observed their firm holding their pasteurized vacuum-packaged RTE surimi-based seafood analog products in a walk-in cooler observed to be at (redacted)°F for up to (redacted) days before (redacted). Additionally, temperature records for this (redacted) cooler indicated temperatures were (redacted)°C ((redacted)°F) and above for over (redacted) times from Feb. 26, 2020, to Mar. 3, 2020, with some deviations lasting (redacted) hours and a maximum temperature of (redacted)°C ((redacted)°F).
In lieu of a control strategy of (redacted) and (redacted) to control C. botulinum, the firm’s HACCP plan at the pasteurization CCP could list critical limits for the critical factors established by a scientific study necessary to achieve a 6-log reduction of type B nonproteolytic C. botulinum along with a CCP for finished product refrigeration at 40°F or below. Currently, their pasteurization CCP lists the hazard of L. monocytogenes which is less heat resistant than C. botulinum.
The firm’s response stated that they have revised their HACCP plans and included new critical control points and copies of their hazard analysis; however, their revised HACCP plans were not included with their response. Their response also stated (redacted). However, their response did not include monitoring records; therefore, it is not clear if they have implemented these activities.
The full warning letter can be viewed here.
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