Jinher, Inc. - 557722 - 10/04/2018

WARNING LETTER

VIA UNITED PARCEL SERVICE

SIGNATURE REQUIRED

October 4, 2018
WL # 557722
Mr. Mohammed M. Rashid, Owner

Jinher Inc.

6240 Prescott Ct

Chino, CA 91710

Dear Mr. Rashid:

The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Jinher Inc., located at 6240 Prescott Ct., Chino, CA 91710on April 23, April 24, April 26, and May 2, 2018. The inspection 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). These violations cause the dietary supplement products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (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.

You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

We received your written response on May 23, 2018, concerning our investigators’ observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on May 2, 2018. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations, noted below.

Dietary Supplement CGMP Violations

The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause dietary supplement products that your facility manufactures, including (b)(4), to be adulterated under section 402(g)(l) of the Act [21 U.S.C. § 342(g)(l)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.

1. You failed to establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR 111.303. Specifically, you do not have written procedures for how you conduct your laboratory operations, nor do you have written procedures for conducting your in-house microbiology analysis or for using your (b)(4) machine.

Once you have established written procedures for laboratory operations, the person who conducts the testing and examination must document, at the time of performance, that the laboratory methodology was followed and must document the results of the testing and examination. 21 CFR 111.325.

You failed to establish specifications for points, steps, or stages 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, as required by 21 CFR 111.70(a). During the inspection, you provided our investigators with a copy of the Certificate of Analysis for (b)(4); however, you were unable to provide established component and finished product specifications when requested by our investigator for the (b)(4) dietary supplement or any other dietary supplement product that you manufacture. Specifically:
1. You failed to establish an identity specification for each component used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1);
2. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2);
3. You failed to establish limits on those types of contaminations that may adulterate or lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(b)(3);
4. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).

We have reviewed your response received May 23, 2018, in which you stated that you are “in the process of obtaining the specifications for the ID machine” and that you will “start comparing ingredients with [the] most recent ingredient tested here at Jinher” until you obtain exact specifications. We are unable to evaluate your response because of a lack of supporting documentation to show that you have established the required component and finished product specifications.

Once you have established specifications, you must determine whether the specifications are met, as required by 21 CFR 111.73 and in accordance with 21 CFR 111.75, as applicable. You must also ensure that the tests and examinations that you use to determine whether the

specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). For example, using previously received lots of raw ingredients as FT-IR reference standards, instead of using qualified compendial or non-compendial reference standard material, to verify the identity of raw ingredients would not be considered a scientifically valid method.

You failed to prepare and follow a written master manufacturing record (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, during the inspection we noted that you are not preparing master manufacturing records that are unique to the product and batch size for each of your dietary supplements being manufactured.

We have reviewed your response received May 23, 2018. We were unable to determine the adequacy of your corrective action because you did not provide documentation of an executed master manufacturing record or a complete master manufacturing record template for a unique formulation of each dietary supplement that you manufacture. When prepared, your master manufacturing records must meet the requirements of 21 CFR 111.210 for all dietary supplements that you manufacture.

Your batch production record (BPR) did not include complete information relating to the production and control of each batch and did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 21 CFR 111.260. For example, your batch production record for (b)(4) did not include the following:

1. The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
2. 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)];
3. The unique identifier that you assigned to each component, packaging, and label used [21 CFR 111.260(d)];
4. 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)];
5. The initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)];
6. The initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv)];
7. Documentation, at the time of performance, of packaging and labeling operations, including 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)]. For example, 1,095 labels were issued for (b)(4); however, 1,136 bottles were labeled, and 1 roll of labels were returned. There was no explanation in the BPR for this discrepancy.

We have reviewed your response, received May 23, 2018, in which you stated that you will document cleaning in a log, you have numbered your rooms and scales, you will add signature and time fields to your BPR, and you have added a cross-reference to the label control form on your BPR. We were unable to determine the adequacy of your corrective action because you did not provide documentation to support revision of your dietary supplement BPR templates to address the noted violations, and that the corrections have been implemented into your manufacturing processes.

You failed to calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.27(b). Specifically, the last time your firm calibrated your scales was in August 2017. Additionally, your firm last calibrated the test weights in May 2014. You must calibrate:

a. Before first use [21 CFR 111.27(b)(1)];

b. At the frequency specified in writing by the manufacturer of the instrument and control [21 CFR 111.27(b)(2)] or;

c. At routine intervals or as otherwise necessary to ensure the accuracy and precision of the instrument and control [21 CFR 111.27(b)(3)].

We have reviewed your response, received May 23, 2018, in which you stated that you will calibrate scales daily in the morning and that you have contacted an outside business to calibrate scales. We are unable to determine the adequacy of your corrective action because you did not provide documentation to support you have conducted the manufacturer-specified periodic calibration, and that you are conducting routine calibration checks on the scales you are currently using in testing of components or in the manufacture of your dietary supplements.

You failed to ensure each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, has the education, training, or experience to perform the person’s assigned functions, as required by 21 CFR 111.12(c).

Specifically, you failed to ensure that employees are trained to perform their assigned functions, as shown by the issues with the (b)(4) machine. You stated to our investigators that for training on the (b)(4) machine, you tried looking up videos on how to use your machine. However, your firm is not conducting the (b)(4) analysis correctly and is not documenting the results correctly. Our investigators also noted that you are not providing the annual training to employees required by your Standard Operating Procedure 80-18-001.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. It is your responsibility to ensure that your products comply with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter and prevent their recurrence or the occurrence of other violations. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction or seizure.

We offer you the following CGMP comment:

Your firm provided a template complaint form, Customer Complaint Form 70-16-002, that aligns with your complaint handling procedure, SOP 90-16-002. However, you are not currently using the template. During the inspection you provided a complaint log in a notebook, but it does not provide information on how the product was used, a reply to the complainant, findings of the investigation, and the follow-up action taken for every complaint. While your firm has met the requirement of 21 CFR 111.553 of having a written procedure, your firm’s compliance with 21 CFR Part 111, Subpart O, “Product Complaints,” will be reviewed during the next inspection.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any 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. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover the FDA’s costs for certain activities, including reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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, the FDA may assess fees to cover any reinspection-related costs.

Your response should be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Compliance Branch, HAF Division West 5, HFR-PA150

19701 Fairchild
Irvine, CA 92612

Refer to Unique Identification Number 557722 when replying.

If you have any questions regarding this letter, please contact Sara J. Dent Acosta, Compliance Officer, at sara.dent@fda.hhs.gov or (619) 941-3767.

Sincerely,

/S/

Darla Bracy, Division Director

Office of Human and Animal Foods

Division 5 West

Cc:

Benson Yee

Chief, Food and Drug Branch

California Department of Public Health

1500 Capitol Avenue, MS-7602

P.O. Box 997435

Sacramento, CA 95899-7435

U.S. Food and Drug Administration

Jinher, Inc. MARCS-CMS 557722 — October 04, 2018