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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.
La Yongjia Trade Co.
Vernon, 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 19 warning letter, the FDA described a Feb. 15-23 Foreign Supplier Verification Program (FSVP) inspection of La Yongjia Trade Co. in Vernon, CA.
The inspection was initiated because of findings of Listeria monocytogenes in samples of fresh enoki mushrooms from the firm’s foreign suppliers, (redacted), located in (redacted), (redacted), located in (redacted), (redacted) and (redacted), located in (redacted), (redacted), located in (redacted), and (redacted), located in (redacted), collected and analyzed by FDA and imported by their company. The firm’s foreign suppliers, (redacted) were placed on Import Alert # 99-23, Detention Without Physical Examination of Fresh Produce Due to Contamination with Human Pathogens, on July 18, 2022, Sept. 23, 2022, June 17, 2022; Feb. 3, 2023, and Sept. 23, 2022, respectively. Fresh enoki mushrooms from their foreign supplier (redacted) were placed on Import Alert # 99-35, Detention Without Physical Examination of Fresh Produce that Appears to have been Prepared, Packed or Held under Insanitary Conditions, on June 14, 2022, respectively. The FDA also notes that fresh enoki mushrooms from their foreign suppliers (redacted) and (redacted) were placed on Import Alert #99-35 on March 13, 2023.
The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. 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:
Fresh Enoki Mushrooms from foreign manufacturer and supplier (redacted), located in (redacted).
Fresh Enoki Mushrooms from foreign manufacturer (redacted) and foreign manufacturer and supplier (redacted), located in (redacted).
Fresh Enoki Mushrooms from foreign manufacturer (redacted) and foreign manufacturer and supplier (redacted), located in (redacted).
Fresh Enoki Mushrooms from foreign manufacturer and supplier (redacted), located in (redacted).
Fresh Enoki Mushrooms from foreign manufacturer (redacted) and foreign manufacturer and supplier (redacted), located in (redacted).
The full warning letter can be viewed here.
Premier Food Supplies LLC
Troy, MI
An import company in Michigan is on notice from the FDA for not having FSVPs for a number of imported food products.
In a July 14 warning letter, the FDA described a March 14-23 Foreign Supplier Verification Program (FSVP) inspection of Premier Food Supplies LLC in Troy, MI.
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:
1. The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for the foods from the foreign suppliers indicated in the attached list.
2. The firm did not meet the requirement to conduct a written hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required. Although they may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, the firm must document their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. Specifically, for the firm’s Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd., located in India, while they obtained the hazard analysis for each of these products from their foreign supplier, they did not document their review and assessment of the hazard analyses or that the hazard analyses were conducted by a qualified individual, as required.
3. The firm did not meet the requirement to evaluate their foreign supplier’s performance and the risk posed by the food, as required, and document their approval of their foreign suppliers based on this evaluation, as required. Specifically, for their Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd. in India, and Cut Mango Pickle with Garlic imported from (redacted), located in (redacted), they did not provide documentation that they have evaluated their foreign supplier’s performance and the risk posed by the food, as required.
4. The firm did not meet the requirement to perform foreign supplier verification activities as required. Specifically, they did not document their determination of the appropriate supplier verification activity or activities, including the frequency with which the activity or activities must be conducted, for their Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd. and Cut Mango Pickle with Garlic imported from (redacted), as required, nor did they conduct (and document) or obtain documentation of one or more appropriate supplier verification activities for each of these foreign suppliers before importing these foods and periodically thereafter, as required.
The full warning letter can be viewed here.
Nafta Distributors Inc.
Ontario, 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 21 warning letter, the FDA described a Feb. 7-21 Foreign Supplier Verification Program (FSVP) inspection of NAFTA Distributors Inc. in Ontario, CA.
The FDA’s inspection revealed that the firm was not in compliance with 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:
Lollipop and Candy Specialties, imported from (redacted)
Candy, imported from (redacted)
Blended vegetable oils, imported from (redacted)
(Redacted) jam, jelly, preserves, marmalade, butter or candied, and candy, imported from (redacted)
Cookies, caramel, and candy, imported from (redacted)
(Redacted) and lollipop, imported from (redacted)
Milk and cream, or candy bar or ieces, imported from (redacted)
Gelatin, imported from (redacted)
Candy specialties, chewing gum, imported from (redacted)
Gelatin, imported from (redacted)
(Redacted), lollipop, candy specialties, chewing gum, imported from (redacted)
(Redacted), jam, jelly, preserves, marmalade, butter and candied, caramel candy bar, soft candy, lollipop, candy specialties, imported from (redacted)
Candy specialties, imported from (redacted)
Gelatin, imported from (redacted)
Peanuts, candy bar, marshmallow candy, chocolate candy, imported from (redacted)
Pepper sauce, imported from (redacted)
Candy, imported from (redacted)
Soda water, imported from (redacted)
Salt, imported from (redacted)
The full warning letter can be viewed here.
Cheshni Foods LLC
Arlington Heights, 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 July 14 warning letter, the FDA described a March 22 through April 28 Foreign Supplier Verification Program (FSVP) inspection of Cheshni Foods LLC in Arlington Heights, IL.
The FDA’s inspection revealed that the firm was not in compliance with 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:
Fig Jam and cookies (tea biscuits), imported from (redacted) in (redacted) located in (redacted)
Tahini, imported from (redacted) located in (redacted)
The full warning letter can be viewed here.
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