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.
Ramar International Corporation
A food company in California is on notice from the FDA after Listeria was found during an inspection of their manufacturing facility.
In an Oct. 13 warning letter, the FDA described a May 20 through June 5, 2020 inspection at Ramar International Corporation manufacturing facility. The FDA found that the firm had significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
In response, the FDA issued the firm a Form FDA 483.
The significant violations:
Hazard Analysis and Risk-Based Preventive Controls :
The firm’s hazard analysis did not identify a known or reasonably foreseeable hazard that requires preventive control. The firm did not appropriately evaluate environmental pathogens to determine whether they are a hazard requiring a preventive control in accordance. The firm’s manufacture ice cream, an RTE food product that is exposed to the environment at several processing steps where it could be contaminated with environmental pathogens, such as L. monocytogenes, and the ice cream does not receive a subsequent control for environmental pathogens. Specifically, during their “Mixing” and “Blending of Inclusions” processing steps, RTE ingredients (such as purees, inclusions, flavors, and colors) are added to RTE ice cream products post-pasteurization where they are exposed to the environment before being packaged. The firm’s Hazard Analysis for “Magnolia Frozen Ice Cream,” dated June 29, 2019, which covers all ice cream products manufactured at their facility, indicates “ None” for potential biological food safety hazards at the “Mixing” and “Blending of Inclusions” processing steps, but they did not include an evaluation of environmental pathogens, even though they produce an RTE food exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Their rationale for concluding that they have no potential biological food safety hazards at the “Mixing” and “Blending of Inclusions” processing steps is based on, among other things, consideration of their Sanitation Standard Operating Procedures (SSOPs). Therefore, they inappropriately determined that there are no biological hazards that require preventive control at these steps because of control measures they are using. Sanitation controls for environmental pathogens are necessary when RTE foods are exposed to the environment and there are no subsequent steps that would significantly minimize the hazard.
Environmental swabs collected during the inspection by FDA on May 21, 2020, detected L. monocytogenes at the following locations:
- Bottom left corner of the door between the (redacted) freezer and RTE Production Room
During the inspection investigators observed employees moving from the (redacted) freezer through this door to the RTE Production Room. Various electrical cords were observed lying on the floor in the RTE Production Room. During the walk-through of sanitation operations on June 2, 2020, investigators observed the same cords draped over pieces of equipment, including the (redacted) freezer conveyor. They swabbed the (redacted) freezer conveyor on April 3, 2020, and April 15, 2020, and found Listeria spp. both times.
- Bristles of a broom that was observed propped up against a ladder and wall in the Cooler Passageway Room
During the inspection, investigators observed an employee using this broom to sweep water in the RTE Production Room during manufacturing operations. This area includes the same employee foot path described above. Employees repeatedly walked across this floor area and other areas of the RTE Production Room. Additionally, during the inspection investigators observed two other brooms stored with bristles in contact with the wet Cooler Passageway Room floor. Investigators then observed a sanitation employee bring one of the brooms into the RTE Production Room on two separate occasions to sweep coconut strings up from two drains. These same drains were swabbed during their environmental sampling on April 3, 2020, and were found positive for Listeria spp.
Whole genome sequencing (WGS) was conducted on three (3) L. monocytogenes isolates (two of three locations are described above and the third isolate was from an exterior ground drain) which were obtained from the FDA environmental sample INV 1109268 collected on May 21, 2020 during our inspection. The WGS analysis determined that the isolates represent a single strain of L. monocytogenes. These isolates are also genetically identical to one clinical isolate collected in 2019, which indicates this strain has the capability of causing human illness. The FDA advised them of those WGS results via a conference call on June 24, 2020.
Furthermore, reviewing their environmental monitoring program, the FDA notes that they have repeatedly found Listeria spp. in their processing facility. Specifically, on April 3, 15, and 20, and May 15, 2020, they conducted environmental swabbing which resulted in recurring findings of Listeria spp. in their RTE Production Room. Some of these findings were in repeat locations, including the pint filler conveyor and (redacted) freezer conveyor. In response to each of these findings, they took similar corrective actions (which included ceasing production, cleaning and sanitizing their equipment and production area, implementing changes to cleaning programs, and re-testing sites). However, it appears that their corrective actions were not adequate to address the findings, as evidenced by the recurring findings of Listeria within their environment, including some within the same locations.
On May 12, 2020, the firm initiated a voluntary recall of their Peekaboo brand Mint Chocolate Chip with Hidden Spinach Ice Cream (Best Before 10/08/2021) that was manufactured on April 8, 2020, after their internal testing detected L. monocytogenes in the product. Further, after the recall and during the FDA inspection, their environmental swabbing on May 20-22 also detected Listeria spp. in three locations, including a drain in their RTE Production Room.
The firm identified improper employee handling of boxes of chocolate chips that were transported into the RTE Production Room via dollies and placed on the floor before being added to the (redacted) machine as the root cause of L. monocytogenes finding in the recalled lot of Peekaboo brand ice cream. Their corrective actions included prohibiting the use of floor dollies on the production floor and replacing them with a (redacted) cart for transporting and holding inclusions in the RTE Production Room. However, on May 21, 2020, this cart was observed sitting outside the building with one of its wheels in standing ground water. They swabbed this ground surface on May 21, 2020, and the result was positive for Listeria spp. On May 27, 2020, this cart was observed inside the RTE Production Room and they did not have a process for cleaning and sanitizing it when bringing it from the outside into the RTE Production Room.
These findings demonstrate that their sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in their facility. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.
The firm committed to performing corrective actions in their written response dated June 26, 2020. Their written response indicates that they hired a consultant, performed intensified cleaning and sanitizing of their production area and equipment, implemented a test and hold program for finished products, and conducted GMP training for employees. Their response also indicates that they are working to revise their food safety plan (including their SSOPs and environmental monitoring program), reassess the hygienic zoning of traffic flow from production areas to non-production areas (including restricting carts to production areas), and make structural facility changes. Their response states that they will complete a hazard re-assessment that includes recontamination as a reasonably foreseeable hazard that requires a preventive control, as well as an ingredient “risk assessment” by July 31, 2020. Additionally, they state that they will complete revisions and assessments to their SSOPs and their Environmental Pathogen Sampling Corrective Action SOP along with employee training by September 14, 2020, and provide bimonthly updates on their progress. Although they provided a summary of the corrective actions that they have taken, their response does not include documentation of the implementation of their corrective actions, updated programs and procedures, and records demonstrating the effectiveness of their corrections. Specifically, their response does not include documentation such as steps taken to identify and correct the problems, environmental swabbing results since the close of the inspection, results of their microbiological test and hold program for finished products implemented on May 25, 2020, training records, or their revised hazard analysis and preventive control program. The FDA recommends that they continue to implement these corrective actions to ensure that L. monocytogenes does not contaminate their RTE food products. To date, no additional updates or responses have been received. The FDA will verify the implementation and adequacy of these corrective actions during their next inspection.
Current Good Manufacturing Practice:
- The firm did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for contamination of food. Further, their “GMP 2019” procedure states that “Drip or condensate from fixtures, drains or pipes must not be allowed to fall into and contaminate food, ingredients, food contact surfaces or food packaging materials.” However, the following conditions were observed during the inspection:
- Liquid build-up was dripping from the (redacted) filler hose directly onto a box of exposed finished product container lids that were being used to package the Magnolia branded Ube Ice Cream (Best By 05/20/2021).
- Apparent liquid drops from a previous cleaning operation observed on the rear railing of the (redacted) which is above and in close proximity to the openings of (redacted) tanks which contained (redacted) at the time. This (redacted) was used in the production of Magnolia brand Ube Ice Cream (Best By 05/20/2021).
- During the production of Magnolia branded Buko Pandan Ice Cream (Best By 05/27/2021), liquid build-up on the hose from the (redacted) Ice Cream Machine was dripping above and in close proximity to the front auger opening of the (redacted) Machine where Buco Strings Preserved (Production Date 12/6/2019; Best By 12/5/2020 were exposed.
The firm’s response states that they have installed a (redacted) to protect packaging, product, and food contact surfaces from drip and positioned outfeed hoses to minimize the potential for dripping, and that they plan to reduce condensation (redacted). Their response also states that they have updated their sanitation checklist to include fixtures, drains, and pipes. Although their response included photos of the physical improvements, they did not provide evidence of the implementation and training of employees on their new procedures. The FDA will verify the implementation and adequacy of these corrective actions during our next inspection.
- The firm did not keep the grounds in a condition that would protect against the contamination of food. Specifically, their operations involve transporting ingredients from a warehouse located in a separate building to the RTE Production Room. Their “GMP 2019” states “Maintain yard, parking lot and drainage in good repair so they do not attract pests or be a source of contamination.” However, on May 20, 2020, Investigators observed that the ground area located outside within the path where materials and ingredients are transported from the warehouse to the RTE Production Room was in disrepair. Specifically, the area outside of the RTE Production Room roll-up and man doors included gravel and pooled/standing water. This is also the designated area for the cleaning and sanitation of plastic pallets, black trash bins, and gray ingredient thaw bins before they are brought into the RTE Production Room.
The firm’s response indicates that they have replaced the gravel with concrete, installed sanitizer (redacted) units at doorways, and required that wheels of carts, hand trucks and forklifts be periodically sanitized to further minimize the potential for the introduction and spread of Listeria in the facility. Although their response includes photos of the physical improvements, they did not provide evidence of implementation and training of employees on their new procedures. The FDA will verify the implementation and adequacy of these corrective actions during our next inspection.
- They did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. Specifically, on May 20, 2020 (the first day of the inspection), there was no sanitizer available at the RTE Production Room handwash sink.
Their response states that they have added hand sanitizer containers at each hand washing station and will verify that sanitizer is available (redacted). Their response also includes a copy of refresher training given to their employees on June 15, 2020. The FDA will verify the implementation and adequacy of these corrective actions during our next inspection.
- They did not clean and sanitize utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. Investigators observed the use of a high-pressure hose during cleaning and sanitizing of floors and equipment, leading to overspray on equipment that comes into direct contact with RTE ice cream products. Specifically:
- A sanitation employee was observed using a high-pressure hose to spray drained cream on the floor towards a floor drain, causing water and contents from the floor to be sprayed back up onto the (redacted) Machine. The employee also used the high-pressure hose to spray his boots while in close proximity to the previously cleaned (redacted) Machine. The floor drain, near where the hose was being sprayed, was found positive for Listeria spp. during their (redacted) environmental sampling on May 21, 2020.
- Employees were observed using a high-pressure hose to spray the drained sanitizer contents from a (redacted) tank on the floor towards a floor drain, causing splash to hit an empty gray cart. This same drain was found positive for Listeria spp. on April 3, 2020. The gray cart had previously been used to hold parts of the (redacted) Machine prior to transfer to the (redacted) tank. After being cleaned in the (redacted) tank, the parts were placed back onto this dirty gray cart. Additionally, investigators observed a product filler hose partially fall onto the uncleaned floor from the same gray cart, exposing the opening of the product filler hose to the floor while (redacted) contents were being drained onto the floor and sprayed by a high-pressure hose. The product filler hose remained in direct content with the dirty floor for approximately 45 minutes before an employee placed it back onto the cart with other previously cleaned equipment. Inadequately cleaned and sanitized floors can serve as niches or harbors for L. monocytogenes in food processing facilities. Water splashing off such floors may be a potential source of L. monocytogenes on food contact surfaces which can ultimately contaminate finished product.
The firm’s response states that they are training employees to not begin cleaning in a room until all clean equipment and carts have been removed from the room or fully covered with plastic sheeting. The firm’s response also states they are investigating ways to no longer discharge food (redacted) and to use (redacted) to move food on the floor to drains. Additionally, their response indicates that they have ordered sanitary hose nozzles that restrict flow of water, that high-pressure hoses will be removed from the plant, and that their staff is receiving sanitation training on the risk of cross-contamination. However, their response does not include evidence of their revised procedures and of employee training. The FDA will verify the implementation and adequacy of these corrective actions during our next inspection.
The firm thaws frozen ingredient-containing bags in a (redacted) sanitizer solution. During production of Magnolia brand Ube Ice Cream on May 20, 2020, bags of Ube (redacted) were observed being thawed in large bins containing such a sanitizer solution. The bags were not rinsed with water after they were removed from the sanitizer solution. While an employee filled the (redacted) mixing tank with the (redacted), excess sanitizer solution was observed dripping into the tank. (redacted) is not intended to become a component of their ice cream products.
Their response indicates they are now using (redacted) to remove excess sanitizer solution on the exterior of the bags before packaging is opened and product is introduced into the mixer. However, their firm should ensure that sanitizers are used according to the instructions and indications for use specified on the product label. Thawing frozen ingredient-containing bags of product in a sanitizer solution may present the potential for product contamination. The FDA will evaluate their corrections during the next inspection.
The full warning letter can be viewed here.
OCM Group USA Inc.
City of Industry, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 16 warning letter, the FDA described a May 15 through 19, 2020, Foreign Supplier Verification Program (FSVP) inspection at OCM Group USA 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:
- Crushed Chili, imported from (redacted)
- (redacted) (Sesame), imported from (redacted)
The full warning letter can be viewed here.
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