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.

CATSMO LLC, Wallkill, NY
Markus Draxler, CEO
In a March 25 warning letter the FDA described a Nov. 18 – Dec. 12, 2019, inspection at CATSMO LLC in Wallkill, NY. Inspectors found that the company has serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP). The FDA also collected environmental samples and found the presence of Listeria monocytogenes.

The FDA’s inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations. The agency inspection revealed the following violations:

Presence of L. monocytogenes
FDA laboratory analysis of the environmental samples collected on Nov. 19, 2019, during the processing of RTE cold smoked salmon, confirmed 5 of the 78 environmental swabs collected were positive for L. monocytogenes. Of the positive findings, 3 swabs were collected from food-contact surfaces which included the scissors/cutting board used to trim RTE cold smoked salmon; the surface of the conveyor belt at the start of the skinner used to skin the RTE cold smoked salmon, and the slicer used to cut the RTE cold smoked salmon.

FDA findings indicate that the firm is neither achieving satisfactory control against the presence of L. monocytogenes within their facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. 

Seafood HACCP
Significant deviations are as follows:

1. The firm must monitor conditions and practices during processing with sufficient frequency to ensure compliance with the current good manufacturing practice requirements that are appropriate to their plant and the food being processed. However, the firm did not monitor the following conditions and practices with sufficient frequency to ensure compliance with  current good manufacturing practice requirements (CGMPs):

A. The firm did not monitor conditions and practices with sufficient frequency to ensure that all plant equipment and utensils are so designed and of such material and workmanship as to be adequately cleaned and adequately maintained to protect against allergen cross-contact and contamination. Specifically, FDA investigators observed the following:

A cutting board in the smoked salmon slicing and packing room used to cut and trim RTE cold smoked salmon fillets was observed to be heavily gouged which does not allow for adequate cleaning and sanitizing.

Worn edges with a buildup of black residue were observed on plastic trays used to hold RTE salmon fillets during salting.

B. The firm did not monitor conditions and practices with sufficient frequency to ensure that effective measures are taken to protect finished food from contamination. Specifically, FDA investigators observed the following:

Cleaning operations were being performed in the salting room wher several racks of exposed RTE salmon fillets were being staged for salting. An employee was using a high-pressure water hose to spray the floor several feet away from the exposed rack of RTE salmon fillets. There was no separation of these activities in order to prevent cross contamination from aerosolized overspray.

A high-pressure water hose with handle and nozzle head was used to rinse scissors, knives, and other utensils in between cutting and trimming RTE cold smoked salmon in the smoked salmon slicing and packaging room and was also used at the end of the production day to wash equipment, including food contact surfaces such as conveyor belt parts and blades to the slicer. An employee was observed handling the hose and nozzle and then touching various utensils and equipment during and after cleaning. A swab collected from the nozzle of the hose was found positive for L. monocytogenes. In addition, this hose was observed to be used to rinse the scissors on which L. monocytogenes was identified.

C. The firm did not monitor conditions and practices with sufficient frequency to ensure that their plant is constructed in such a manner that condensate from fixtures, ducts and pipes does not contaminate food, food contact surfaces, or food-packing materials. Specifically, on Nov. 19, 2019, FDA investigators observed condensation accumulating on the condenser unit fans on the ceiling of the brining room and dripping on and around white plastic trays used to salt and season RTE salmon fillets during brining. This is a repeat observation noted during previous inspections.

The full warning letter can be viewed here.

Cafe Valley Bakery, LLC, Phoenix, AZ
Brian Owens, CEO
In a March 18 warning letter the FDA described a Nov. 5 – Dec. 17, 2019, inspection at Cafe Valley Bakery LLC in Phoenix, AZ. Inspectors found that the company has serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation. Additionally, the FDA collected environmental samples from various areas in the processing facility and analysis of the environmental swabs found the presence of Listeria monocytogenes.

The FDA acknowledged receipt of the firm’s response to the FDA-483,  on Jan. 6, which included corrective actions taken and planned. However, the FDA’s evaluation of the response revealed it was not adequate. After reviewing the responses that the firm provided, the FDA is issued this letter to advise the company of the the agency’s concerns and provide detailed information describing the findings at their facility.

FDA inspection revealed the following violations:

Hazard Analysis and Risk-based Preventive Controls:
The firm is required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated. In their food safety plan, they identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate resident strains of L. monocytogenes in the facility, they did not implement sanitation controls adequate to ensure that the facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes.

FDA laboratory analysis of the environmental a sample collected on Nov. 5, 2019, during the production of RTE croissants confirmed 19 of 76 environmental swabs collected tested positive for L. monocytogenes. Of the positive findings, two swabs were collected from (redacted) that transport unpackaged RTE croissants from a (redacted) to packaging. The remaining swabs were collected from various non-food contact surfaces, including inside the croissant (redacted), the floor underneath the croissant production line, the muffin (redacted), underneath the muffin (redacted) from the (redacted), the floor in the cake (redacted), and the wheel on a (redacted) cart used throughout their facility.

In addition, L. monocytogenes was found in environmental samples collected at the facility during FDA inspections in 2016 and 2018. In 2016, L. monocytogenes was found in five environmental swabs of the floors and drains. In 2018, L. monocytogenes was found in three environmental swabs of the floors and drains. The microbiological strains of L. monocytogenes were isolated from the environmental swabs. In general, one strain was isolated from each sample. However, two different strains of L. monocytogenes were identified in one subsample from 2016.

Whole genome sequencing (WGS) was conducted on the 19 L. monocytogenes isolates obtained from the 2019 FDA environmental samples, six L. monocytogenes isolates obtained from the 2016 environmental samples, and three L. monocytogenes isolates obtained from the 2018 environmental samples. By inference of the evolutionary relationships, the analysis of WGS data from bacterial human pathogens enables high resolution comparison between isolates. The current WGS analysis determined that the isolates derived from the samples collected at the facility during the three inspections represent three strains of L. monocytogenes, and two of the three strains appear to have been present in their facility since 2016.

One strain of L. monocytogenes was identified in five isolates from the 2016 inspection, one isolate from the 2018 inspection, and nine isolates from the 2019 inspection.

A second strain of L. monocytogenes was identified in one isolate from 2016, one isolate from 2018, and four isolates from 2019.

A third strain of L. monocytogenes was found in one isolate from 2018 and six isolates from 2019. 

The presence of the same strains of L. monocytogenes over multiple years indicates there have been multiple resident pathogens in the facility since 2016. 

The reoccurring presence of L. monocytogenes in the facility is significant in that it demonstrates their sanitation efforts are inadequate to significantly minimize or prevent L. monocytogenes in their facility. 

The FDA acknowledged that the firm voluntarily destroyed all croissant products produced between the cleaning performed before and after the environmental samples were taken. The firm’s written response outlines the corrective actions they plan to take and those they have implemented, including hiring a third party (redacted) company to (redacted) with (redacted), retraining sanitation employees, switching sanitizing chemicals used for (redacted) of the (redacted), increasing the concentration of (redacted) used in their “(redacted)” process, increasing the (redacted) concentration in their foot baths, (redacted) and (redacted) floor cleaning tools, increasing environmental swabbing from (redacted) swabs a (redacted) to (redacted) swabs a (redacted), employee traffic areas and areas around the floor and feet of product (redacted), and addressing (redacted) within the (redacted) of the croissant (redacted) and along the croissant (redacted).

Current Good Manufacturing Practice:

1. The firm did not conduct operations in accordance with adequate sanitation principles nor take adequate precautions to ensure that production procedures did not contribute to contamination. Specifically,

• The firm was running (redacted) production on the croissant line without performing a full production line cleaning with (redacted) for approximately (redacted). (redacted) production runs without sanitation increases the probability of pathogens surviving in the environment and contaminating product.

• Wheeled production carts were observed being used throughout the facility without being cleaned and sanitized before moving to different areas of production. FDA recovered an L. monocytogenes positive environmental swab from the wheel of one of the carts used in production.

• Throughout the inspection, employees were observed moving in between different areas and stages of production, such as the raw material production and finished product packaging, without taking any measures to prevent cross-contamination, such as changing outer garments and using foot baths containing sanitizer.

Before the conclusion of the inspection, the company stated that they were going to reduce their production runs to (redacted) and implement a sanitation procedure for (redacted) cleaning of packaging food contact surfaces during (redacted) production. The response states they have changed their employee traffic patterns, imposed movement restrictions and created traffic patterns that cause employees to make use of foot baths, limited foot traffic in areas surrounding their production sanitation washroom, and segregated equipment from employee walkways. The firm states that they have (redacted) and are monitoring the sanitizer concentration (redacted) in the foot baths. 

2. The plant was not constructed and designed to facilitate maintenance and sanitary operations and permit taking of adequate precautions to reduce the potential for contamination of food contact surfaces. On December 13, 2019, FDA investigators observed the accumulation of (redacted) within the (redacted) of the croissant line and along the (redacted) directly above the croissant (redacted) from the (redacted). This area of production is just prior to packaging of the RTE croissants. Swabs collected from the (redacted) at the croissant (redacted) tested positive for L. monocytogenes.

3. The firm did not keep buildings, fixtures, and other physical facilities in repair adequate to prevent food from becoming adulterated. On December 13, 2019, FDA investigators observed the food contact surface of the (redacted) on the croissant line (redacted) and touching (redacted). This (redacted) is located post baking and before the (redacted) for the croissant line wher (redacted) were observed.