Editor’s note: 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 companies that have received warning letters this week will be taking them more seriously after Sept. 15 when the FDA for the first time, issued a consent decree of permanent injunction against a firm for violating public safety standards under the Produce Safety Rule. This injunction comes two years after sending a warning letter to the firm and more than nine years after gaining the power to do so.
Canyon Farms, 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 a July 16 warning letter, the FDA described an April 17 through May 5, 2020, Foreign Supplier Verification Program (FSVP) inspection at Canyon Farms, 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’s significant violations of the FSVP regulation are as follows:
- The firm did not meet the requirements to conduct a hazard analysis for the products they import. Specifically, for their Whole Dill Pickles, imported from their foreign supplier (redacted), located in (redacted), and their Minced Garlic imported from their foreign supplier (redacted), located in (redacted), do not have a hazard analysis. For their Sweet Pickle Relish, Whole Dill Pickles, and Nacho Sliced Jalapeno Peppers imported from their foreign supplier (redacted), located in (redacted), while they have obtained a hazard analysis from their foreign supplier for each of these products, they did not document their review and assessment of their foreign supplier’s hazard analysis.
- The firm did not meet the requirements to evaluate their foreign supplier’s performance for the products they import. Specifically, for their Minced Garlic imported from their foreign supplier (redacted), located in (redacted), they did not provide supplier evaluation information. For their Whole Dill Pickles, imported from their foreign supplier (redacted), located in (redacted), while they have obtained a “Foreign Supplier Approval Survey” from their supplier (redacted), they did not document their evaluation of this information or their approval of this supplier. For their Sweet Pickle Relish, Whole Dill Pickles, and Nacho Sliced Jalapeno Peppers imported from their foreign supplier (redacted), located in (redacted), while they have obtained a “Foreign Supplier Approval Survey” from their supplier (redacted), they did not document their evaluation of this information or their approval of this supplier.
- The firm did not meet the requirements to perform foreign supplier verification activities for the products they import. Specifically, they did not document their determination or performance of appropriate supplier verification activities for the Whole Dill Pickles or Sweet Pickle Relish imported from their foreign supplier (redacted), located in (redacted), or for the Whole Dill Pickles, imported from their foreign supplier (redacted), located in (redacted). For their Minced Garlic imported from their foreign supplier (redacted)., located in (redacted), they obtained several audit certificates, but the certificates do not include audit procedures or refer to specific FDA regulations. For their Nacho Sliced Jalapeno Peppers imported from their foreign supplier G.O.C Food Processing Export JSC, while they obtained a Certificate of Analysis and Lab Test Report, they did not establish written procedures for ensuring that appropriate supplier verification activities are conducted and they did not document their determination of the appropriate supplier verification activity.
The full warning letter can be viewed here.
Babylon, Inc
Niles, IL
An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Sept. 3 warning letter, the FDA described a May 7 and 8, 2020, remote Foreign Supplier Verification Program (FSVP) inspection for Babylon, Inc.
The inspection was initiated based on isolation of Salmonella, from a sample of tahini manufactured by (redacted). The FDA acknowledged that the firm voluntarily destroyed all tahini manufactured by (redacted). 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:
- Tahini manufactured by (redacted).
- Tahini manufactured by (redacted).
- Tahini manufactured by (redacted).
The full warning letter can be viewed here.
For additional information on FDA redactions, please see this recent opinion piece.
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