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.

Apia Export Fish Packers LTD — Apia, Samoa

The Food and Drug Administration sent a warning letter dated Jan. 8, 2020, to the Managing Director of Apia Export Fish Packers LTD, John Luff.

During an inspection at Apia Export Fish Packers LTD’s seafood processing facility on Aug. 26-27, 2019, FDA investigators found serious violations of the seafood Hazard Analysis and Critical Point (HACCP).

In response to these deviations, the FDA issued an FDA Form 483 Inspectional Observations report that lists deviations observed at the facility.

The violations noted by the FDA:

1. “You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point 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 revised HACCP plan for “Chilled and Frozen Fish”, which covers your fresh tuna products that you provided with your September 10, 2019, response does not list the critical control point of chilled storage (i.e., holding prior to shipping/flights) for controlling the food safety hazard of scombrotoxin (histamine) formation.”
2. “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 revised HACCP plan for “Chilled and Frozen Fish”, which covers your fresh tuna products that you provided with your September 10, 2019, response lists critical limits at the “(redacted)” critical control point that are not adequate to control the food safety hazard of scombrotoxin (histamine) formation that is reasonably likely to occur onboard the harvest vessels. Your firm is was observed to be a (redacted) processor, receiving the fish directly from the harvest vessels. Consequently, in order to ensure that fish were properly handled while onboard the vessels in manner that controls scombrotoxin (histamine) formation that is reasonably likely to occur onboard the harvest vessels, FDA recommends that, in addition to your critical limits of internal temperature of the fish and sensory examination at receipt, you establish critical limits for harvest vessel records or histamine testing.”

• “For the harvest vessel record strategy, FDA recommends that all scombrotoxin-forming fish lots received are accompanied by harvest vessel records that show:”
• “Fish exposed to air or water temperatures above 83°F (28.3°C) were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 6 hours from the time of death;”
•  “Fish exposed to air and water temperatures of 83°F (28.3°C) or less were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 9 hours from the time of death;”
• “Fish that were gilled and gutted before chilling were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 12 hours from the time of death;”
• “Fish that were harvested under conditions that expose dead fish to harvest waters of 65°F (18.3°C) or less for 24 hours or less were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than the time limits listed above, with the time period starting when the fish left the 65°F (18.3°) or less environment;”
•  “Other critical limits for onboard handling (e.g., maximum refrigerated brine or seawater temperature, maximum fish size, maximum fish to brine/seawater/ ice ratio, maximum initial temperature of the fish) necessary to achieve a cooling rate that will prevent development of an unsafe level of histamine in the specific species, as established through a scientific study.”

“For fish held refrigerated (not frozen) onboard the vessel:”

• “The fish were stored at or below 40°F (4.4°C) after cooling;”
• “The fish were stored completely and continuously surrounded by ice after cooling.”
• “For the histamine testing strategy, FDA recommends:”

“Analysis of a representative sample of scombrotoxin-forming fish shows less than 50 ppm histamine in all fish in the sample.”

“Further, it is not clear whether your corrective action plans at the “(b)(4)” critical control point ensure that no adulterated product enters commerce. The corrective action of “(redacted)” should clarify that the you will “(b)(4)”, not just individual fish from the lot.”

3. “You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm was observed to not be monitoring the “(redacted)” or “(redacted)” at the “(redacted)” critical control point to control the scombrotoxin (histamine) formation hazard listed in your HACCP plan for “Chilled and Frozen Fish”, which covers your fresh tuna products.”
4. “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 in your revised HACCP plan for “Chilled and Frozen Fish”, which covers your fresh tuna products that you provided with your September 10, 2019, response is not adequate at the “(redacted)” critical control point to control the hazard of scombrotoxin (histamine) formation. In addition to your listed corrective action of rejecting the lot when deviations occur from your critical limits for internal temperature of the fish, FDA recommends that you also discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices and controls have been improved to ensure the cause of the deviation is corrected.”

Additional comments:

“FDA recommends that firms include the following monitoring procedures in their HACCP plans at receiving:”

“For internal temperature measurement:”

• “The internal temperature of fish using a temperature-indicating device (e.g., a thermometer) to measure the internal temperature of a representative number of the largest fish in each lot at the time of off-loading from the harvest vessel. concentrating on any that show signs of having been mishandled (e.g., inadequately iced) for every lot of scombrotoxin-forming fish received. For example, when receiving 10 tons or more of fish, measure a minimum of one fish per ton, and when receiving less than 10 tons of fish, measure a minimum of one fish per 1,000 pounds. Measure a minimum of 12 fish, unless there are fewer than 12 fish in the lot, in which case measure all of the fish. Randomly select fish from throughout the lot. Lots that show a high level of temperature variability or lots of very small fish may require a larger sample size.”
• “Date and time of off-loading by visually determining the date and time of off-loading for every lot of scombrotoxin-forming fish received.”

“For sensory examination:”

• “Amount of decomposition in the lot by examining at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish) for every lot of scombrotoxin-forming fish received. Additional fish should be examined if variability in fish-to-fish histamine content is expected to be high. Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species. All fish within a lot should have a similar history of harvest.”

A complete list of the violations can be found in the FDA’s warning letter.

Fujian Guangyang Egg Industry Company Limited — Fuzhou, China

The Food and Drug Administration sent a warning letter dated Dec. 26, 2019, to Chairman of Fujian Guangyang Egg Industry Company Limited, Jie Yu.

During an inspection at Fujian Guangyang Egg Industry Company Limited‘s low-acid canned food (LACF) facility on Sept. 19, 20, and 23, 2019, FDA investigators found serious violations of the Emergency Permit Control regulation. 

In response to these deviations, the FDA issued an FDA 483, Inspectional Observations that lists deviations observed at the facility.

The violations noted by the FDA:

1. “Your firm’s processing and production information was not recorded at the time it was observed, as required by 21 CFR 113.100(a). Specifically, the investigators requested production records for (redacted) batches, but the records provided were created for our review during the (redacted) hours it took your firm to produce the records and did not reflect processing and production information recorded at the time of observation. Our review of processing records revealed (redacted) out of (redacted) production batches of Cooked Salted Duck Eggs (SID (redacted)) and Marinated Eggs (SID (redacted)) destined for the United States (U.S.) contained different copies of (redacted) operator logs, in which the processing data in one document did not match the data in the other. (redacted) operator logs created for our review were compared to electronic data captured by your (redacted) recorders. The written record created for FDA review did not match actual processing conditions for processing times, critical factors, parameters, quantity and number of (redacted) loads processed. Additionally, our investigators discovered another copy of the operator’s log in the (redacted) operating room that contained different data from the (redacted) operator logs created for our review.”

“Your October 21, 2019, and December 12, 2019, responses state that offices have been re-planned and records re-filed and stored. The October 21 response states the records must have been from the original records. Your December 12 response states that employees were fined for making false records. We are unable to evaluate the adequacy of your corrective actions because you did not provide supporting documentation.”

2. “Your firm failed to maintain records to identify the initial distribution of finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use, as required by 21 CFR 113.100(f). Specifically:”
3. “During record review of (redacted) out of (redacted) batches of product destined for the U.S., the lot code written on shipping documentation did not match the lot code on the production records discovered in the (redacted) room.”
4. “(redacted) operator logs discovered by our investigator in the (redacted) room had batch records consisting of only the production date. This information is insufficient to identify specific food lots. Batch records should contain product, lot code and batch size information.”
5. “The original record used the date as the lot code (i.e. 2019.6.19). The fabricated ones changed the batch record to match what was shipped to the U.S. and adjusted the quantity produced to show that enough of that particular batch was made for the shipment. For example, Marinated Eggs with batch code (redacted) and shipped to the U.S. on July 7, 2019 were reportedly processed on June 19, 2019 and June 20, 2019. However, the (redacted) operator log that was discovered during the inspection from the (redacted) room denotes different batch codes of “(redacted)” and “(redacted)” for product manufactured on those dates respectively. In addition, the quantity of product manufactured during these (b)(4) days ((redacted) units) was less than the documented quantity of product shipped to the U.S. ((redacted) units).”
6. “On September 19, 2019, we observed multiple pallets of marinated eggs in clear, unmarked pouches and tea eggs in cups located in your (redacted) workshop finished product storage area with no identifying code on the individually packaged eggs or identifying the pallets containing clear, unmarked pouches. For product intended for distribution in the U.S., there was no code applied to the individual marinated egg pouches that were combined into a multi-pack unit. There was no way to determine when the marinated eggs were (redacted) processed and, therefore, insufficient records to identify specific food lots.”
7. “On September 19, 2019, we observed an unlabeled pallet of tea eggs in cups and an unlabeled pallet of single packed marinated eggs in clear pouches. An employee was observed creating a label for the tea cup pallet as produced on September 18, 2019. On September 20, 2019, the unlabeled pallet of single packed marinated eggs in clear pouches was observed with a production label of September 18, 2019. However, this conflicts with the production log from September 18, 2019, and (redacted) different employee statements that cups and clear pouches were not manufactured on September 18, 2019.”
8. “Lot codes that are applied to finished product consist of the year, customer batch and product. They do not identify the establishment, date of production or period of packing for the following LACF products:”

Product	Lot Code	Production Date
Marinated Egg	(b)(4)	6/19/19, 6/20/19
Marinated Egg	(b)(4)	3/23/19, 3/ 24/19

“This information is insufficient to identify the initial distribution of specific food lots.”

• “Your October 21, 2019, and December 12, 2019, responses state that you have implemented new traceability control procedures. You also note that the production batch number has been revised and after “(redacted)“, a label card with product information will be mounted on each product vehicle, and label of semi-finished products will include product name, quantity, batch number and production date. Your responses also state that employees were punished for making false records. We are unable to evaluate the adequacy of your corrective actions because you did not provide adequate supporting documentation.”
• “Your firm failed to review temperature-recording device records no later than one working day after the actual process, as required by 21 CFR 113.100(b). These records must be reviewed before shipment or release for distribution, by a representative of plant management who is qualified by suitable training or experience to review all processing and production records for completeness and to ensure that the product received the scheduled process. The records, including temperature-recording device records, must be signed or initialed and dated by the reviewer. Your firm failed to review and initial or sign these records. Specifically:”“You did not print out or review the electronic data captured by the (redacted) recorders installed on your (redacted). (redacted) out of (redacted) batches of US product reviewed during the inspection for product shipped to the U.S. did not have any temperature charts included.”
• “There is no evidence that the (redacted) temperature recording chart for each batch was reviewed.”

“Your October 21, 2019, response states records of (redacted) have been printed out and reviewed within one working day. Your December 12, 2019, response included a production record stating that you had reviewed the temperature-recording device records. Your response is inadequate because your review of the production record did not identify discrepancies between the actual processing conditions and the filed critical factors in the scheduled process.”

• “Your firm failed to record a critical factor specified in the scheduled process as required by 21 CFR 113.100(a). Specifically, you do not maintain a record of flow rate, which is defined as a critical factor for your LACF egg products processed in (redacted). There are no operator logs or electronic data in your (redacted) recorder to document the flow rate for the following (redacted) out of (redacted) batches of LACF product destined for the U.S.:”

SID	Product	Lot(s)
(b)(4)	Cooked Salted Egg	(b)(4)
(b)(4)	Marinated Egg	(b)(4)

“Your October 21, 2019, response states a flowmeter has been purchased and will be installed by November 11, 2019 and you will notify FDA once installed. The response is inadequate because it does not address food products manufactured after the inspection without monitoring flow rate and how this affects their scheduled process. You provided an additional response on November 6, 2019, with information regarding the installation of a flowmeter and a blank sterilization record. However, we are unable to evaluate the adequacy of your response because you did not address food products manufactured since the inspection and did not provide supporting documentation, such as how employees were trained on the installation and use of the new equipment. Your December 12, 2019, response provided a production record, but this response is inadequate because the documented flow rate is not in agreement with your firm’s filed process.”

A complete list of the violations can be found in the FDA’s warning letter.

Mission LLC — Renton, WA

The Food and Drug Administration sent a warning letter dated Feb. 06, 2020, to the Owner of Mission LLC, Yoon Chang.

During a Foreign Supplier Verification Program (FSVP) inspection at Mission LLC on Aug. 2 and 5, 2019. FDA investigators found serious violations of that the company was not in compliance with the requirements of 21 CFR part 1 subpart L for their black tea imported from foreign supplier (redacted)., located in (redacted). The firm did not have an FSVP for this product, or any food products which they import.

In response to these deviations, the FDA issued an FDA 483, Inspectional Observations that lists deviations observed at the facility.

The violations noted by the FDA:

“Your firm did not have FSVPs for the products that you import, including the black tea imported from foreign supplier (redacted)., located in (redacted). During our July 2018 inspection, we similarly found that you did not have FSVPs.”

A complete list of the violations can be found in the FDA’s warning letter.