WARNING LETTER
Green Explosion, Inc.
MARCS-CMS 609209 —
August 20, 2020
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Alejandro Gomez
Recipient Title
Director
Green Explosion, Inc.
6960 NW 25 Street
Miami
,
FL
33122
United States
accounting@greenexplosionherbs.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV
United States
WARNING LETTER
20-HAFE4-WL-07 /CMS No. 609209
Ms. Libia Gomez, President
Dear Mr. Gomez and Ms. Gomez:
The United States Food and Drug Administration (FDA) inspected your facility located at 6960 NW 25 Street, Miami, Florida on May 19, 2020 and May 21, 2020. FDA initiated the inspection after reviewing a State’s laboratory analysis of a retail sample of your “Wild Harvest” brand organic basil, which demonstrated the presence of
Cyclospora cayetanensis
, a human parasite that can only multiply in the human gut, making humans the only reservoirs. A finding of
Cyclospora cayetanensis
on produce is evidence of direct or indirect contamination of the produce with human feces. Accordingly, basil represented by this sample is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that it was prepared, packed, or held under insanitary conditions whereby it became contaminated with filth and whereby it may have been rendered injurious to health. We acknowledge that your firm voluntarily recalled lot
(b)(4)
of “Wild Harvest Organic Fresh Basil” on May 7, 2020.
On April 27, 2020, the State of Minnesota Department of Agriculture collected a retail sample of lot 112 of your “Wild Harvest Organic Fresh Basil.” The State’s laboratory analysis of the sample, dated and provided to FDA on April 30, 2020, demonstrated the presence of
Cyclospora cayetanensis
. During our inspection, you informed our investigator that the organic basil from lot
(b)(4)
. Further, you provided our investigator the proper traceability paperwork specifically for the shipment of organic basil lot
(b)(4)
. Introduction of such an adulterated food product into interstate commerce is a prohibited act under Section 301(a) of the Act [21 U.S.C. § 331(a)].
The above is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products that you import and distribute are in compliance with all requirements of the Act and applicable federal regulations. You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in legal action by the FDA without further notice, including, without limitation, seizure and injunction.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct and subsequently prevent the distribution of adulterated products. You should include documentation in your response, such as photographs, food safety plans(s), procedures, or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection or finding that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, San Juan District Office, 466 Fernández Juncos Avenue, San Juan, PR 00901-3223, to the attention of Mr. Ramon A. Hernandez, Director.
We would like to meet with you to further discuss
Cyclospora cayetanensis
contamination and your response to these findings. A virtual meeting has tentatively been scheduled for Tuesday, September 22, 2020, at 2:00 p.m. (eastern standard time). Due to the ongoing public health concern presented by COVID-19, this meeting will be held via conference call. If you have any questions regarding this letter or this meeting, please contact Ms. Laura Kennedy, Compliance Officer, via e-mail at Laura.Kennedy@fda.hhs.gov. Please reference CMS No. 609209 on any documents or records you provide to us and/or within the subject line of any e-mail correspondence you send us.
Sincerely,
/S/
Ramon A. Hernandez
District Director, San Juan District
Program Division Director,
Office of Human and Animal Food Operations,
East Division IV
Content current as of:
09/01/2020
Regulated Product(s)
Food & Beverages