Inspections, Compliance, Enforcement, and Criminal Investigations

Summit Nutritionals International 5/31/17

 

  

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WARNING LETTER

CMS#521980 

May 31, 2017
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Dr. Caesar DePaco, Owner
Summit Nutritionals International, Inc.
1250 Route 28, Suites 305B, 306 & 308
Branchburg, NJ 08876
 
Dear Dr. DePaco:
 
The U.S. Food and Drug Administration (FDA) inspected your facility located at 1555 Lyell Ave., Rochester, NY 14606-2145, on June 21, 23 and 27, 2016 and again on February 27, 2017 which operates a re-packer of bulk dietary ingredients for your parent frrm, Summit Nutritionals International, Inc., 29 Rockaway Road, Lebanon, NJ, 08833..
 
Our investigator collected receiving records and labeling for your product labeled as Hydrolyzed Salmon Collagen Powder 90% Protein. We have reviewed receiving records and labeling and found violations of the food labeling regulations, 21 CFR Part 101, that cause your product to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. You can find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
 
Your Hydrolyzed Salmon Collagen Powder 90% Protein product is misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product label is false and misleading in any particular. Specifically, during the inspection your product was observed being repackaged and relabeled as Hydrolyzed Salmon Collagen Powder 90% Protein; however, the product is actually Hydrolyzed Gelatin sourced from (b)(4).  Additionally, the manufacturer's label for the Hydrolyzed Gelatin product states thatit is "MADE IN CHINA." Whereas the label for the Hydrolyzed Salmon Collagen Powder 90% Protein states that it is "Proudly Made in The USA" and the Certificate of Analysis states "Country of Origin: United States of America" which makes it appear that the country of origin labeling is also false and misleading. Food labeling statements regarding geographical origin must not be false or misleading in any particular. See Compliance Policy Guide (CPG) Sec. 560.200 Country of Origin Labeling for more information at https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074567.htm.
 
We note that additional inspections of your parent firm, Summit Nutritionals International, Inc., 29 Rockaway Road, Lebanon, NJ, 08833 on October 26, 2015 through November 10, 2015 and again on August 15, 2016 through September 13, 2016 also indicated similar misbranding violations may be occurring with your porcine, bovine and/or chicken collagen products. We recommend that you review all of your product labels to be consistent with our policy to avoid additional misbranding of your food products.
 
This letter is not meant to be an all-inclusive list of the violations that exist at your firm or that exist in connection with your products. You are responsible for ensuring that your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations in this letter. Failure to promptly correct the violations may result in enforcement action without further notice, such as seizure or injunction.
 
We offer the following comments:
 
1.    Records must be maintained that demonstrate-that products are not manufactured from, processed with, or does not otherwise contain prohibited cattle materials [21 CFR 189.5(c)(1)]. During the inspection it was determined your firm receives collagen derived from (b)(4) products or by-products; however, your firm was not able to provide any documentation to support the materials are free from bovine spongiform encephalopathy (BSE). Your firm also stated you do not have any established specifications for animal-derived ingredients to ensure they are BSE free. 
 
2.     The product label fails to declare the net quantity of contents as required by 21 CFR 101.7. For example, statements of weight shall be declared in terms of avoirdupois pound and ounce in accordance with 21 CFR 101.7(b)(1).
 
You should respond in writing within fifteen working days from your receipt of this letter outlining the specific steps that you have taken to correct these violations. You should include in your response documentation such as revised product labels and website information, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. 
 
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer.
 
                                                           
Sincerely,
/S/ 
Evelyn Bonnin                                                                                   
Program Division Director
HAF Division 2 E 
 

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