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WARNING LETTER
CMS # 613680

Dear Mr. McElroy:

From January 27, 2021 to February 9, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of McElroy Imports located at 92 Wendy Lane, Glen Mills, PA 19342. We also conducted a FSVP inspection on June 11, 2019. 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 your Creamy Caramels with Sea Salt imported from (b)(4) located in (b)(4); (b)(4) Tea Bags imported from (b)(4) located in (b)(4); and (b)(4) imported from (b)(4) located in (b)(4). 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 FSVP inspection on June 11, 2019 and the follow-up inspection on February 9, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge your response email dated February 9, 2021. You stated that you would “advise (b)(4) of your concern and get back to you asap along with the other companies.” During the inspection, you provided copies of an audit report titled BRCGS Food Safety, Certificate of Registration, NSF Certificate of Conformity, and an FDA Establishment Inspection Report from your foreign supplier (b)(4). You also provided a SAI Global Certificate of Conformity for (b)(4), the manufacturer of (b)(4). You did not provide any documents regarding your foreign suppliers (b)(4) or (b)(4), both located in (b)(4). We address your documents below.

Your significant violations of the FSVP regulation are as follows:

1. You did not develop, maintain, or follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for each of the following foods:

• (b)(4) Tea Bags imported from (b)(4) located in (b)(4)
• (b)(4) imported from (b)(4) located in (b)(4)

2. For Creamy Caramels with Sea Salt from your foreign supplier (b)(4), although you provided documents regarding your foreign supplier, you did not meet your requirements to conduct a hazard analysis in accordance with 21 CFR 1.504, you did not evaluate your foreign supplier’s performance in accordance with 21 CFR 1.505, nor did you perform foreign supplier verification activities in accordance with 21 CFR 1.506. The BRCGS Food Safety audit refers to (b)(4) Hazard Analysis and Critical Control Point (HACCP) plan, but you did not provide the hazard analysis contained in the HACCP plan or document your review. You may meet your requirement to conduct a hazard analysis, as required under 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of that hazard analysis (21 CFR 1.504(d)). The FSVP regulation also generally requires that you evaluate your foreign supplier’s performance (21 CFR 1.505). You did not provide documentation of your evaluation of your foreign supplier’s performance. With respect to the requirements of 21 CFR 1.506, while you may rely on third party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor and that they assessed compliance with FDA food safety regulations, as required by 1.506(e). You must also promptly review and assess any third-party audit that constitutes a verification activity, as well as document your review and assessment, among other requirements (21 CFR 1.506(e)).

(b)(3)(A)

The above matters 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.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in 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 food products you import that appear to be in violation of section 805. We may place the foods you import from the identified foreign suppliers 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 any 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: Pasquale Leone, Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Pasquale.Leone@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Leone via email at Pasquale.Leone@fda.hhs.gov. Please reference CMS # 613680 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Dawne Hines
Program Division Director
Division of Northeast Imports