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WARNING LETTER

Ida Foods LLC MARCS-CMS 610356 —


Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages

Recipient:
Recipient Name
Andrea L. Pratt
Recipient Title
Director of Product Development
Ida Foods LLC

1417 6th St Ste 301
Santa Monica, CA 90401-2599
United States

Issuing Office:
Division of West Coast Imports

United States


Dear Ms. Andrea L. Pratt:

From June 23, 2020 to July 2, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Ida Foods LLC located at 1417 6th St Ste 301, Santa Monica, CA 90401-2599.  We also conducted an inspection on August 28, 2018.  These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
  
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.  You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
    
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for creamer stick imported from Lakeland Dairies Inc., Ireland; cream biscuit imported from Ceylon Biscuits Ltd., Sri Lanka; and bottled water imported from Societe Anonyme Des Eaux Minerales D 'Evian, France.  Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. 

At the conclusion of both the initial inspection in 2018 and the follow-up inspection in 2020, our investigator provided you in each instance with Form FDA 483a, FSVP Observations.  As of this date, we have not received a response from you.

Your significant violations of the FSVP regulation are as follows: 

1. You did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a control in accordance with 21 CFR 1.504(a).  You may rely on the hazard analysis of your foreign supplier to meet your obligations under the FSVP regulation, however, you did not provide FDA with any evidence that you documented your review and assessment of your foreign supplier’s hazards analysis as required per 21 CFR 1.504(d).  Specifically, for your creamer stick imported from Lakeland Dairies Inc. located  in Ireland, while you obtained a document entitled “HACCP Introduction” from Lakeland Dairies Inc, and documented your review and assessment, this document does not identify that it pertains to the creamer stick.  In addition, for your cream biscuit imported from Ceylon Biscuits Ltd. located in Sri Lanka and your bottled water imported from Societe Anonyme Des Eaux Minerales D ‘Evian’ located in France, you did not have a hazard analysis. 

2. You did not establish and follow adequate written procedures to ensure you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a)(2), and document your approval, as required by 21 CFR 1.505(b).  Specifically, your FSVP manual state (b)(4).  

3. You did not determine and document which verification activity or activities or frequency of such  must be conducted, to provide adequate assurances that the hazards requiring a control in the food you import has been significantly minimized or prevented as required by 21 CFR 1.506(d).  Specifically, for your creamer sticks imported Lakeland Dairies Inc., located in Ireland, cream biscuits imported from Ceylon Biscuits Ltd., located in Sri Lanka, and the bottled water imported from Societe Anonyme Des Eaux Minerales D ‘Evian’ located in France, your FSVP Manual states (b)(4).  

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements.  It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.  

You should take prompt action to correct the above violations.  If you do not promptly correct them, we may take further action.  For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food products you import.  We may place the foods you import on detention without physical examination (DWPE) when you import the products.  You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html.  In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.

You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should address the specific things you are doing to correct these violations.  You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation).  If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.  If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Please send your reply to Food and Drug Administration, Attention: Steven L. Robbs, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA  90831.  If you have any questions regarding this letter, you may contact Steven Robbs via email at steven.robbs@fda.hhs.gov.  Please reference CMS #610356 in any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

 
Sincerely,
/S/
Dan R. Solis
Program Division Director
Division of West Coast Imports
 

 
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