Warnings sent to food companies in multiple states for import violations


As part of its enforcement efforts, the Food and Drug Administration is sending warning letters to organizations under its jurisdiction. Some letters are not published until weeks or months after they are sent. The business owner has 15 days to respond to the FDA warning letter. Warning letters are often not issued until the company has been given months or years to fix the problem.


La Aldea Distributors Co., Ltd.
San Antonio, Texas

An import company in Texas has been notified by the FDA that it does not have an FSVP on many imported foods.

In its January 27, 2023 warning letter, the FDA described a Foreign Supplier Verification Program (FSVP) inspection of La Aldea Distributors Inc in San Antonio, Texas from October 20 through November 1, 2022. .

An FDA inspection found the company to be non-compliant with FSVP regulations and issued FDA Form 483a.

Serious violations are:

The company did not develop, maintain and comply with the FSVP. Specifically, we have not created FSVPs for the foods we import, including the following foods:

  • Quince paste imported from (Edited)
  • honey imported from (Edited)
  • Direct imported guava jam (Edited)

You can read the full text of the warning here.

Five Star Trading IL Inc.
Chicago, Illinois

An Illinois import company has been notified by the FDA that many imported foods do not have an FSVP.

In its March 29, 2023 warning letter, FDA describes a Foreign Supplier Verification Program (FSVP) inspection of Five Star Trading IL, Inc., Chicago, Illinois, from November 21 through December 12, 2022. bottom.

An FDA inspection found the company to be non-compliant with FSVP regulations and issued FDA Form 483a.

Serious violations are:

1. The company did not develop, maintain and comply with the FSVP. Specifically, it did not develop, maintain, and comply with FSVP for food from foreign suppliers on the attached list.

2. The business meets the requirement to conduct and document (or document) one or more supplier verification activities for each foreign supplier prior to importing food and on a regular basis thereafter. was not Specifically, they did not conduct and document (or obtain documentation of) one or more such supplier verification activities for their foreign suppliers. (Edited) and (Edited)both (Edited), before and periodically after importing dried black pepper and dried black mold respectively. During the inspection, they provided his FSVP of dried black pepper. It lists the verification activities to be performed, including review of the following documents: Food Safety Plan or HACCP Plan ((Edited) or at reassessment); GMP programs, SSOPs and third party audits ((Edited)); certificate of analysis (microbiological and chemical) ((Edited)); and finished product testing (biological, chemical, physical) ((Edited)). However, while they provided records of end-product testing of dried black peppercorns, they did not document that they had conducted any of the other verification activities listed. documented that the verification activity was determined to be a review of the following documents: HACCP Plan ((Edited) or at reassessment); GMP programs, SSOPs and third party audits ((Edited)); Certificate of Analysis ((Edited)), and finished product testing (biological, chemical, physical) ((Edited)). However, in an email reply dated December 27, 2022, the documentation of the dry black mold verification activity only included a copy of his HACCP plan and sanitary standard operating procedures for the foreign supplier.

3. The company did not promptly document the review and evaluation of the results of verification activities performed by another organization. Specifically, they did not have the documentation to review and evaluate the Food Laboratory report for dried black peppercorns imported from the United States. (Edited)and foreign supplier HACCP plans and sanitary standard operating procedures for dried black mold imported from Japan. (Edited).

4. The firm must make all records required under this subpart readily available for inspection and copying by authorized FDA personnel upon request. At FDA’s request, you must provide English translations of records maintained in languages ‚Äč‚Äčother than English within a reasonable time. However, they did not provide the following English translations of his FSVP documents after investigators requested documents referenced in English: (Edited)To date, they have not yet provided the requested translation of this document.

You can read the full text of the warning here.

Santa Cruz Produce Co., Ltd.
Nogales, Arizona

Arizona importers have been notified by the FDA that many imported foods do not have FSVPs.

In its March 8, 2023 warning letter, FDA explained the November 14, 2022 Foreign Supplier Verification Program (FSVP) inspection of Santa Cruz Produce, Inc., Nogales, Arizona.

An FDA inspection found the company to be non-compliant with FSVP regulations and issued FDA Form 483a.

Serious violations are:

The company did not develop, maintain and comply with the FSVP. Specifically, the company did not make his FSVP for any of the foods it imports, including each of the following:

of.fresh mangoes imported from (Edited)
b. Raw pumpkin imported from Japan (Edited)
c. Raw pumpkin imported from Japan (Edited)

You can read the full text of the warning here.

Milkyway International Trading Corporation
norwalk, california

A California importer has been notified by the FDA that many imported foods do not have an FSVP.

In its April 14, 2023 warning letter, FDA describes the November 4 and November 17, 2022 Foreign Supplier Verification Program (FSVP) inspections of Milky Way International Trading Corporation in Norwalk, California. bottom.

An FDA inspection found the company to be non-compliant with FSVP regulations and issued FDA Form 483a.

Serious violations are:

1. The company did not develop, maintain and comply with the FSVP. Specifically, the company has not created his FSVP for the following foods:

  • Mushrooms, common (Agaricus Bisporus), pieces and stems, imported slices (Edited)
  • artichokes (microgreens) and artichokes (leaf and stem vegetables) (Edited)located in (Edited)
  • Asparagus (microgreens) and asparagus (leaf and stem vegetables) (Edited)located in (Edited)
  • Jerusalem artichoke (root and tuber vegetable) (Edited)located in (Edited)
  • Corn (vegetable) (Edited)located in (Edited)
  • orange (citrus) (Edited)located in (Edited)
  • Pear (core fruit) (Edited)located in (Edited)
  • peach (pit fruit) (Edited)located in (Edited)
  • Asparagus (microgreens) and asparagus (leaf and stem vegetables) (Edited)located in (Edited)
  • orange (citrus) (Edited)located in (Edited)
  • orange (citrus) (Edited)located in (Edited)
  • fruit cocktail, mixed fruit (Edited)located in (Edited)
  • Peach, jam, jelly, preserve, marmalade, butter or candy (Edited)located in (Edited)
  • Other Fruits, Subtropical/Tropical Fruits, Mixes, Toppings, Syrups (Edited)located in (Edited)
  • Mixed fruit, imported from NEC (Edited)located in (Edited)
  • peach (pit fruit) (Edited)located in (Edited)
  • Wasabi, imported products (Edited)located in (Edited)
  • Bamboo shoots (microgreens) and bamboo shoots (leaf and stem vegetables) (Edited)located in (Edited)
  • Heart Of Palm (Edited)located in (Edited)

2. The company did not meet the requirements to conduct foreign supplier verification activities on the products it imports. Specifically, they will determine and document which verification activities or activities and the frequency with which such verification activities or activities must be performed prior to importing food from foreign suppliers. did not meet the requirements. The hazards that require control of the food they import have been greatly minimized or prevented. FSVP for Strawberry Syrup and Blueberry Syrup Imported from Overseas Suppliers (Edited)located in (Edited) and FSVP for canned coconut cream imported from foreign suppliers (Edited)located in (Edited), requires suppliers to provide certain information, including food safety audit information, as part of their supplier verification activities. However, none of these FSVPs indicate how often this verification activity should be conducted. In addition, when asked if they documented the frequency of their verification activities, they did not respond or provide further records of this verification activity. Additionally, while they may rely on third-party food safety audits as part of their foreign supplier verification activities, they should ensure that the audit takes into account applicable FDA food safety regulations.For foreign suppliers (Edited)located in (Edited)A supplier of strawberry syrup and blueberry syrup products, they provided an audit certificate made by (Edited)The certificate states that the supplier meets the requirements of the Global Standard for Food Safety No. 6: July 2011, but is subject to the FDA Food Safety Regulations to which the audit applies and foreign There is no indication that the information relevant to compliance with those regulations by the supplier has been considered. Further, there is no indication that a qualified individual was used to review or evaluate the results of this audit. The Company shall also promptly review and evaluate the results of third-party audits that constitute verification activities, document the review and evaluation of the results of such activities, and ensure that the results do not sufficiently warrant the necessary risk. Appropriate action must be taken if Controls have been significantly minimized or prevented.Field of FSVP for Strawberry Syrup and Blueberry Syrup Products Imported from Foreign Suppliers (Edited)located in (Edited)It has not been completed to indicate whether such products have undergone applicable food safety audits or certifications. The FDA notes that this supplier’s certificate of audit states that he has an expiration date of January 19, 2021. Other documentation relating to verification activities for these products.

You can read the full text of the warning here.

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