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. The FDA frequently redacts parts of warning letters posted for public view.

Sabra Dipping Company, LLC
White Plains, NY

A food firm in New York is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, including the presence of Salmonella Havana in the firm’s ready-to-eat hummus products.

In a Dec. 1 warning letter, the FDA described an April 28 through May 6, 2021, joint inspection with the Virginia Department of Agriculture and Consumer Services (VDACS) of Sabra Dipping Company LLS’s ready-to-eat (RTE) hummus manufacturing facility in White Plains, NY.

The FDA and VDACS Investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation and the inspection resulted in the issuance of an FDA Form 483.

The presence of Salmonella Havana in the firm’s RTE hummus products, as evidenced by the laboratory analysis of FDA’s retail sampling, causes the firm’s recalled Classic hummus products to be adulterated, according to the letter.

On March 26, 2021, the firm was notified by FDA of a retail sample of “Classic Hummus” collected in California that tested positive for Salmonella Havana. In response to these findings, the firm initiated a Class I recall of their Classic Hummus products, which consisted of approximately 16,200 pounds (25,920 10-ounce cups) of product that was distributed in 17 states. Whole genome sequencing of these findings found that this isolate did not match any isolate in the FDA database. FDA advised the company of these findings on May 4, 2021.

During the inspection of the facility, the FDA followed up on the corrective actions that were taken in response to these findings. The agency documented that the food firm conducted a root cause investigation, as described in “S2021 RCA Investigation Summary,” but reported to FDA that the firm was unable to identify a root cause for the problem.

Additionally, during FDA inspection, investigators found that they identified sixteen observations to be corrected by April 26, 2021. These observations mainly include reviewing their SOP and GMP practices for high care areas and retraining their employees. However, a review of the firm’s documentation showed that only two of the 16 corrections were complete by the close of FDA inspection on May 6, 2021.

As of the date on the warning letter, no additional information on the completion of these corrective actions has been provided. In addition, the FDA noted that the root cause analysis described in the company’s summary did not include an investigation of suppliers. Further, the FDA noted that the corrective actions did not indicate that the company conducted a re-analysis of its food safety plan.

The agency is very concerned about the findings of Salmonella in the food firm’s finished product, according to the warning letter.

The full warning letter can be viewed here.

Golden Medal Mushroom Inc.
Los Angeles, 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. 21, warning letter, the FDA described a May 12-13 and May 18, 2021, Foreign Supplier Verification Program (FSVP) inspection of Golden Medal Mushroom Inc. in Los Angeles, CA.

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 firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for any of the foods they import, including each of the following foods:

Enoki mushroom imported from (redacted)
King oyster mushroom imported from (redacted)
Hon shimeji (white) mushroom imported from (redacted)

The full warning letter can be viewed here.

Roal Produce, Inc.
Houston, TX

An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 27, warning letter, the FDA described Feb. 25, March 3 and March 9, 2021, Foreign Supplier Verification Program (FSVP) inspections of Roal Produce Inc. in Houston, TX.

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 firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for any of the foods they import, including each of the following foods: