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.

Thai unio Group PLC

Thailand

A food firm in Thailand is on notice from the U.S. Food and Drug Administration for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

In an April 20, 2022, warning letter the FDA described a Jan. 18-20 and 25, 2022, remote assessment of Thai unio Group PLC.

The FDA’s inspection revealed that the firm was not in compliance with FDA regulations. In accordance with regulation, failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with regulation, renders the fish or fishery products adulterated.

Some of the firm’s significant deviations are as follows:

1. The firm must have a HACCP plan that at minimum lists the critical limits that must be met, to comply with regulations. 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 frozen precooked tuna loins lists a critical limit of “(redacted)” at the Precooking critical control point that is not adequate to control scombrotoxin (histamine) formation. FDA recommends they establish critical limits for the minimum or maximum values for the critical factors established by a scientific study, which may include length of the cook cycle, speed of the belt for a continuous cooker, temperature of the steam or water used for cooking, initial temperature of the product, product form (loin, whole fish, etc.), and any other critical factors that affect the rate of heating the product. Alternatively, the firm may establish a value for the end product’s internal product temperature, established by a scientific study.

The firm’s Temperature Distribution Testing Report and Heat Penetration Testing Report provided during the inspection do not support the listed critical limit of “(redacted).”

a. The Temperature Distribution Testing Report documents the result of temperature distribution within “(redacted)” located at “(redacted)” but the Heat Penetration Testing Report documents results for “(redacted)” and “(redacted)” located at “(redacted).” In order to scientifically validate the cooking process, the scientific studies used to establish critical limits should be conducted for and applied to each individual cook tunnel.

b. Although the “Test Procedure” section of the Heat Penetration Testing Report states that the thermocouples should be placed in the geometric center of the product at the thickest point near the backbone,” photos in the report shows temperature sensors placed in tuna loins and not in whole, headed and gutted or any tunas with backbones. It does not appear that the heat penetration study is representative of the whole tuna processed under the “(redacted)” HACCP plan, which lists the “(redacted)” step as occurring after the “(redacted)” step.

Additionally, the firm’s “(redacted)” is identified as the scheduled process of precooked tuna (For USA) and includes Skipjack, Bigeye, Yellowfin, and Albacore tuna. The document lists multiple sizes for each species and a corresponding “(redacted).” It is unclear how this document relates to the listed critical limit of “(redacted)” or how it relates to the Heat Penetration Testing Report. Since multiple-sized batches are processed, the critical limit should include ensuring each fish of each batch weighs less than a specific maximum size to ensure that all fish are processed to achieve a uniform heat penetration with a minimum internal temperature of 60°C.

2. The firm must have a HACCP Plan that at minimum lists monitoring procedures and their frequency for each critical control point. However, the firm’s HACCP plan for frozen precooked tuna loins lists a monitoring frequency at the following critical control points that is not adequate. Specifically:

a. The unrefrigerated processing critical control points for steps “3-19” lists a monitoring frequency of “-Every bin of raw material – Every trolley of precooked fish” that is not adequate to control scombrotoxin (histamine) formation because it does not include a unit of time between measurements. FDA recommends monitoring cumulative exposure time at a frequency of every 2 hours.

b. The unrefrigerated processing critical control point for steps “19-33, 44” lists a monitoring frequency of “-Every precooked fish trolley” that is not adequate to control scombrotoxin (histamine) formation because it does not include a unit of time between measurements. FDA recommends monitoring cumulative exposure time at a frequency of every 2 hours.

c. The unrefrigerated processing critical control point for steps “22-33,40” lists a monitoring frequency of “-Every precooked fish trolley” that is not adequate to control Staphylococcus aureus growth and toxin formation because it does not include a unit of time between measurements. FDA recommends monitoring cumulative exposure time at a frequency of every 2 hours.

3. The firm must implement the monitoring procedures and frequency that they have listed in their HACCP Plan. However, their firm did not follow the monitoring procedure of “(redacted)” at the unrefrigerated processing critical control point for steps “3-19” (CCP 10) to control scombrotoxin (histamine) formation. FDA recommends continuous ambient temperature monitoring (air and water surrounding fish) from the time a lot of fish exits cold storage until the time a lot of fish enters the (redacted) step.

4. Since the firm chose to include corrective actions in its HACCP Plan, its described corrective actions must be appropriate. However, the firm’s corrective action plan listed at the following critical control points are not appropriate. Specifically:

a. The metal detecting critical control point lists a corrective actions of “If any product was rejected by metal detector, action shall be taken one as following: 1) the fish shall be rejected, or 2) the fish shall be separated for sorting out the metal fragments and after removed the metal fragment, re-pass the fish through metal detector again before releasing” is not adequate because it does not address the cause of the critical limit deviation. In order to regain control over the operation, FDA also recommends the firm attempt to locate and correct the source of the fragments found in the product by the metal detector.

b. The unrefrigerated processing critical control point for steps 3-19 does not ensure unsafe product doesn’t reach the consumer or correct the cause of the critical limit deviation. To ensure unsafe product does not reach the consumer, in addition to their listed corrective action of “perform histamine analysis on the fish lot by analyzing minimum of 60 fish, including all fish that show evidence of decomposition,” FDA recommends they also add instructions to destroy the lot or divert it to a non-food use if any fish is found with histamine greater than or equal to 50ppm. To correct the cause of the critical limit deviation, FDA recommends they modify the process as needed to reduce exposure time. Note that the listed corrective action to “reject the lot which is all raw material bins that take longer than control time and greater than control temperature at each step” is not appropriate because it represents an action taken for a critical limit deviation for processing temperatures, but the CCP does not contain a temperature critical limit.

c. The unrefrigerated processing critical control point for steps 19-33,40 lists a corrective action of “If cumulative time from after precooking until start of freezing exceeds 12 hours, then specifically identify the involved trolley of tuna, segregate and immediately expedite processing, then conduct histamine analysis at cleaning for 60 tuna randomly seleced from the identified racks based on composites from 3 tuna (20 composites) If any composite exceeds 10ppm histamine, then reject all identified rack.- Depending on evidence, each of the 60 individual fish can be analyzed wherby all identified tuna are rejected if any one fish exceeds 30ppm. – Determine and correct cause for the excessive exposure time”. This corrective action is not adequate to ensure unsafe product does not reach the consumer or correct the cause of the critical limit deviation.

To ensure unsafe product does not reach the consumer, FDA recommends the firm:

• chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the affected lot and destroy the lot or divert it to a non-food use if any fish is found with histamine greater than or equal to 50 ppm. The fish collected for analysis may be composited if the action plan is reduced accordingly. For example, a sample of 60 fish may be composited into 20 units of 3 fish each, provided the action point is reduced from 50 ppm to 17 ppm for each unit;

• Or, destroy the product;
• Or, divert the product to a non-food use.
• And: to regain control over the operation and correct the cause of the critical limit deviation, FDA recommends the firm:
• Add ice to the product;
• Or, return the affected product to the cooler;
• And, modify the process as needed to reduce the time and temperature exposure.

d. The Unrefrigerated Processing critical control point for steps 22-33,40 lists a corrective action of “If the accumulated time is more than the critical limits reject the products” that is not adequate to ensure unsafe product does not reach the consumer or correct the cause of the critical limit deviation.

To ensure unsafe product does not reach the consumer, FDA recommends the firm:

• Chill and hold the affected product until an evaluation of total time and temperature exposures is performed;
• Or, destroy the product;
• Or, divert the product to a non-food use.
• And: to regain control over the operation and correct the cause of the critical limit deviation, FDA recommends the firm:
• Determine cause of deviation
• And, modify the process as needed to reduce time and temperature exposure.