WARNING LETTER
Zing Brothers LLC
MARCS-CMS 642819 —
January 23, 2023
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Gary A. Gygi
Recipient Title
Manager
Zing Brothers LLC
2030 N Redwood Rd Suite 70
Salt Lake City
,
UT
84116
United States
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
January 23, 2023
WARNING LETTER
Reference: CMS Case # 642819
Dear Mr. Gygi:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, located at 2030 N Redwood Rd, Suite 70, Salt Lake City, UT 84116 on August 17, 18, 22, and 24, 2022, and we also reviewed labels for your products,
(b)(4)
and
(b)(4)
. Based on inspectional findings and a review of your labels for
(b)(4)
and
(b)(4)
, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
At the close of the inspection, on August 24, 2022, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). Our investigator subsequently issued an amended FDA 483 on August 29, 2022. To date, we have not received a response to the FDA 483.
Adulterated Dietary Supplements
The inspection of your facility on August 17, 18, 22, and 24, 2022, revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). Based on these violations, these products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
Your significant violations of CGMP requirements are as follows:
1. You failed to establish a specification for every point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR 111.70(a). Specifically, for the
(b)(4)
and
(b)(4)
products:
a. You failed to establish component specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b);
b. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
Once you have established the required specifications, you must take specific actions to determine whether those specifications are met, as required by 21 CFR 111.73 and 21 CFR 111.75, and you must make and keep records of all activities relating to such specifications, in accordance with 21 CFR 111.95.
2. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, your firm lacks written procedures for quality control operations.
Once you have established your quality control written procedures, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations, as required by 21 CFR 111.65.
3. You failed to prepare and follow a MMR for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, you do not have MMRs for your
(b)(4)
and
(b)(4)
products. Additionally, your MMR must include all required elements of 21 CFR 111.210.
4. Your batch production records (BPRs) did not include complete information relating to the production and control of each dietary supplement batch that you manufacture, and did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your BPRs for the
(b)(4)
(lot numbers
(b)(4)
and
(b)(4)
) and
(b)(4)
(lot numbers
(b)(4)
and
(b)(4)
) products you manufacture under contract failed to include the following information:
a. The identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)]. For example, you use a blender and pH meter in your manufacturing process; however, you did not document the identity of this equipment.
b. The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)]
c. The unique identifier that you assigned to each component, packaging, and label used [21 CFR 111.260(d)]
d. A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)]
e. Documentation, at the time of performance, of packaging and labeling operations, including:
i. The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels [21 CFR 111.260(k)(1)]
ii. An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR [21 CFR 111.260(k)(2)]
f. Documentation, at the time of performance, of:
i. The initials of the person responsible for adding each component to the batch [21 CFR 111.260(j)(2)(iii)];
ii. The initials of the person responsible for verifying the addition of the components to the batch [21 CFR 111.260(j)(2)(iv)];
g. Documentation, at the time of performance, that quality control personnel:
i. Reviewed the batch production record [21 CFR 111.260(l)(1)];
ii. Approved and released, or rejected, the batch for distribution [21 CFR 111.260(l)(3)];
iii. Approved and released, or rejected, the packaged and labeled dietary supplement [21 CFR 111.260(l)(4)].
5. You failed to establish and follow written procedures for holding and distribution operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distributing operations.
6. You failed to establish and follow written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a). Specifically, you have not established written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement.
Once you have established the required calibration procedures, you must calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement before use, in accordance with 21 CFR 111.27(b).
7. You failed to make and keep documentation of employee training, as required by 21 CFR 111.14(b)(2). Specifically, you do not document employee training, including the date of the training, the type of training, and the person(s) trained
Misbranded Dietary Supplements
In addition, we reviewed product labels collected during the inspection and have determined the
(b)(4)
and
(b)(4)
products you manufacture are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:
1. The
(b)(4)
and
(b)(4)
products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the product labels are false or misleading. Specifically, the product labels state that the products contain
(b)(4)
, and “
(b)(4)
”. This information is false because your BPRs do not include these ingredients as part of the formulation for these products.
2. The
(b)(4)
and
(b)(4)
products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that these product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example, according to your BPRs, both products are formulated with
(b)(4)
, and
(b)(4)
is formulated with
(b)(4)
. However, none of these ingredients is declared on the labels.
3. The
(b)(4)
product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product contains artificial coloring but fails to bear labeling stating that fact. Your BPRs for this product list an artificial
(b)(4)
flavor and this ingredient contains several subingredients, including
(b)(4)
. However, the
(b)(4)
product label fails to declare the presence of this color additive using its listed name or appropriate abbreviation, as required by 21 CFR 101.22(k)(1).
4. The
(b)(4)
and
(b)(4)
products are misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. For example,
a. The
(b)(4)
and
(b)(4)
product labels list
(b)(4)
within the list of (b)(3)-dietary ingredients in the Supplement Facts panel. A (b)(2)-dietary ingredient must not be listed with the (b)(3)-dietary ingredients in accordance with 21 CFR 101.36(b)(2) and (b)(3).
b. The
(b)(4)
product label declares 27 calories. The amount must be expressed in the increments specified in 21 CFR 101.9(c)(1), as required by 21 CFR 101.36(b)(2)(ii)(A).
5. The
(b)(4)
and
(b)(4)
products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
We also have the following comment:
We would like to remind you of the requirement to establish packaging and label specifications, as required by 21 CFR 111.70(d) to ensure the packaging that may come into contact with dietary supplements is safe and suitable for its intended use and is not reactive or absorptive or otherwise affect the safety or quality of the dietary supplement.
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.
Please send your written response to the following address: 6th Avenue and Kipling Street, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087, to the attention of Compliance Officer Carrie Jolly or by email (preferred) to carrie.jolly@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Compliance Officer Carrie Jolly at carrie.jolly@fda.hhs.gov or (303) 236-9656.
Sincerely,
/S/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
Content current as of:
02/28/2023
Regulated Product(s)
Food & Beverages