WARNING LETTER
New Manna Food
MARCS-CMS 652996 —
June 12, 2023
Delivery Method:
United States Postal Service
Product:
Food & Beverages
Recipient:
Recipient Name
Eunha Yoon
Recipient Title
Owner/President
New Manna Food
PO Box 315990
Tamuning
96931-3890
Guam
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
WL 652996
Dear Ms. Yoon:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat prepared foods facility, to include seafood, New Manna Food, located at #102 Luisa St., Tamuning, GU 96931 from February 1, 2023, through February 3, 2023. During the inspection of your facility, FDA found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123). In accordance with 21 CFR, failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish and fishery products adulterated with the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. A label review was also conducted of the Guam New Manna Foods tuna salad sandwich and found violations of Food Labeling, Title 21, Code of Federal Regulations (CFR), Part 101 (21 CFR Part 101) which causes the product to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Additionally, the inspection found the firm failed to register as required in section 415 of the Act [21 U.S.C. § 350d), and FDA's implementing regulation at 21 CFR Part 1, Subpart H [21 CFR 1.225 -1.243]. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)]. You may find the Act, the seafood HACCP regulation, and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.
At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA 483), Inspectional Observations, listing the deviations found at your facility. To date, we have not received a response. We have the following remaining concerns to the violations noted in this letter below.
Seafood HACCP Violations
1. You do not have a written HACCP plan that outlines controls for any food safety hazards that are reasonably likely to occur, as required by 21 CFR 123.6(b). Specifically, your firm does not have a HACCP plan for Guam New Manna Foods tuna salad sandwich to control
the hazards of histamine, pathogen growth and toxin formation, and undeclared allergens. In addition, your firm has not conducted a hazard analysis for this product. Our investigator observed the following lack of controls during the inspection:
a) On 2/1/2023 at 11:00 am, the temperature of your walk-in refrigerated storage was measured at 44°F using the gauge on the wall of the walk-in storage. There were ingredients used in your tuna salad sandwich stored in this cooler at the time the temperature was observed, including tuna and mayonnaise. Finished product Guam New Manna Foods tuna salad sandwich were also observed being stored in this walk-in storage. You stated that the sandwiches would be distributed the next morning at about 4:30 am.
On 2/2/2023 at 9:15 am, the temperature of the walk-in storage was measured at 48.7°F using a probe thermometer (the accuracy of which was checked using ice water). At 9:35 am, the temperature was 46.2°F and at 11:48 am, the temperature was 47.3°F using the same probe thermometer. At all these times, mixed tuna salad was stored in the walk-in storage awaiting assembly into Guam New Manna Foods tuna salad sandwiches. You state that the finished product Guam New Manna Foods tuna salad sandwiches would be stored in the walk-in storage until distribution the next morning at about 4:30 am. You stated that you do not monitor or record the temperature of your walk-in storage. There is no continuous monitoring of the temperature, and no temperature alarm system on the walk-in storage.
b) Your Guam New Manna Foods tuna salad sandwiches are not labeled with a statement of identity, an ingredient statement, or allergen statement. The product contains the allergens of milk and soy from the bread, egg from mayonnaise, and fish (tuna).
2. You are not monitoring the sanitation conditions and practices with sufficient frequency to ensure compliance with Current Good Manufacturing Practice requirements including protection from adulteration (i.e., allergen cross contact) and exclusion of pests from the food plant, as required by 21 CFR 123.11(b).
Specifically,
a) On 2/1/2023, our investigator observed at least four flies inside your processing room. The flies were observed landing on bread used for ready-to-eat Tuna Salad Sandwiches and on other ready-to-eat products and food contact surfaces.
b) On 2/1/2023, our investigator observed ham and cheese sandwiches were being manufactured, and then placing the in-process sandwiches directly on a stainless-steel table. After the ham and cheese sandwich manufacturing was completed, Guam New Manna Foods wiped off using a towel that was wet with plain water and proceeded to place tuna salad sandwiches on the same table. Our investigator also observed the same potential cross contact issues after the manufacture of the tuna salad sandwiches where egg salad sandwiches could be potentially adulterated with fish allergens from the work surface. When allergen cross contact presents a food safety hazard, processors must implement prevention controls that effectively remove or eliminate allergens from the work surface. Wiping down food contact surfaces with water does not appear to provide the necessary safety assurance that allergens have been eliminated from that surface. FDA recommends that cleaning operations include two steps, washing the surface with soap to remove particulates and then sanitizing the cleaned surface. The processor also has the option of scheduling the products being manufactured to eliminate the potential for allergen cross contact.
Modified Requirements for Qualified Facilities (Subpart D)
Your facility meets the definition of a qualified facility1 under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food rule (CGMP & PCHF rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117), and therefore is subject to the modified requirements in 21 CFR 117.201. A qualified state facility is required to submit an attestation to FDA that the facility is a qualify facility (21 CFR 117.201(a)(1)). In addition, a qualified facility is required by 21 CFR 117.201(a)(2) to submit one of the two following attestations to FDA:
An attestation that you have identified the potential hazards associated with the food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or
An attestation that the facility is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a state department of agriculture), or other evidence of oversight.
To date you have not submitted such an attestation.
Misbranding Violations
1. Your Guam New Manna Foods tuna salad sandwich product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the finished product label fails to declare the major food allergens wheat, milk, tuna, and egg, as required by section 403(w) of the Act. Specifically, your Guam New Manna Foods tuna salad sandwich product is manufactured using tuna, mayonnaise (which contains egg), and bread (which contains wheat and milk).
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines “major food allergens” as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)]; or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
2. Your Guam New Manna Foods tuna salad sandwich product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product label fails to bear the common or usual name of the food. For example, the product name “sandwich” is not an appropriately descriptive term for a product that contains tuna salad, in accordance with 21 CFR 101.3. In addition, the statement of identity shall be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed, as required by 21 CFR 101.3(d).
3. Your Guam New Manna Foods tuna salad sandwich product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight measure, or numerical count as required by 21 CFR 101.7.
4. Your Guam New Manna Foods tuna salad sandwich product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Specifically, the label contains only your firm name and telephone number.
5. Your Guam New Manna Foods tuna salad sandwich product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4(a). For example, your product is manufactured using canned tuna, mayonnaise, bread, and lettuce; however, you fail to list these ingredients and their sub-ingredients on your finished product label.
We also offer the following comments:
Your Guam New Manna Foods tuna salad sandwich label contains dual language. If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language, as required by 21 CFR 101.15(c)(2).
Our investigator noted you also manufacture an egg salad sandwich and a ham and cheese sandwich, in both of which you use mayonnaise and bread. Please note that any label corrections made to the tuna salad sandwich label must be made to all of your finished product labels, including all mandatory labeling information such as the ingredient statement, allergen labeling, place of business, net quantity of contents, etc. As a manufacturer, it is your responsibility to ensure your product labels are compliant with FDA regulations.
Your Guam New Manna Foods tuna salad sandwich product fails to bear nutritional information as required by 21 CFR 101.9. Specifically, your tuna salad sandwich label does not bear nutrition information (e.g., a Nutrition Facts Label).
FDA finalized updated requirements for nutrition labeling on May 27, 2016. Manufactures must revise labels to meet these requirements. See https://www.fda.gov/food/food-labelingnutrition/changes-nutrition-facts-label. These Nutrition Facts label regulations include updated nutrient declaration and formatting requirements.
Note that a firm may be eligible to file for a small business nutrition labeling exemption for low-volume products found in 21 CFR 101.9(j)(18) if the firm claiming the exemption employs fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a 12-month period. For this exemption, a notice must be filed annually with FDA.
For more information on the nutrition labeling exemptions under 21 CFR 101.9(j)(18), see the SBNLE guidance at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm053857.htm].
Failure to Register
We have determined that your facility has failed to register your facility. Your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d), and FDA's implementing regulation at 21 CFR Part 1, Subpart H [21 CFR 1.225 -1.243]. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that, to date, this facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by this facility's owner, operator, or agent in charge, must register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov2. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA industry Systems Help Desk at 1-800 216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form maybe faxed to (301) 436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to address the violations noted in this letter. Failure to adequately address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be directed to:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
San Francisco District Office
1201 Harbor Bay Parkway
Alameda, CA 94502
or emailed to ORAHAFWEST5FirmResponses@fda.hhs.gov.
Refer to the Unique Identification Number CMS 652996 when replying.
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations- West Division 5
__________________
1
See definition of “qualified facility” in 21 CFR 117.3
Content current as of:
07/11/2023
Regulated Product(s)
Food & Beverages