- Delivery Method:
- United Parcel Service
- Kumato Labs
2646 Saint Louis Avenue
Signal Hill, CA 90755-2024
- Issuing Office:
- Los Angeles District Office
| || |
Los Angeles District
19701 Fairchild, Irvine CA 92612-2506
VIA United Parcel Service
February 3, 2017
Mr. Richard Waggoner, CEO
2646 Saint Louis Avenue
Signal Hill, CA 90755-2024
Dear Mr. Waggoner:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, Kumato Labs, located at 2646 Saint Louis Ave, Signal Hill, California, on August 31 and September 8, 2016. 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 your dietary supplement products 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)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. You may find the Act and the CFR through links on FDA’s home page at www.fda.gov.
We acknowledge your response letter, dated September 9, 2016, to the Form FDA 483, Inspectional Observations, issued to you at the conclusion of the inspection on September 8, 2016. Our comments regarding the adequacy of your corrective actions are detailed after the applicable violations, noted below.
During the inspection, our FDA investigator observed the following significant violations of the CGMP requirements for dietary supplements:
1. Your firm failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, during the inspection, a representative of your firm was unable to provide our investigator with written procedures for reviewing and investigating product complaints.
In addition, a representative of your firm stated that your firm has received complaints primarily related to satisfaction with the product, but not complaints of sickness or illness. We note that you must make and keep a written record of every product complaint that is related to good manufacturing practice, as required by 21 CFR 111.570(b)(2).
We have reviewed your response dated September 9, 2016. In your response, you state that you have created standard operating procedures for reviewing and investigating product complaints and are keeping records of product complaints. We intend to verify the adequacy of your corrective actions at a future inspection.
2. Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, during the inspection, a representative of your firm stated to our investigator that you do not have written procedures for holding and distributing operations.
We have reviewed your response dated September 9, 2016. In your response, you state that you are in the process of developing procedures for holding and distribution operations. We intend to verify the adequacy of your corrective actions in a future inspection.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.
You should take prompt action to correct and prevent the reoccurrence of the violations specified above as well as the other violations outlined on Form 483, List of Inspectional Observations, issued at the close of inspection. Failure to do so may result in an enforcement action by FDA without further notice, including, without limitation, seizure and injunction.
We note that you state your firm operates as a dietary supplement warehouse and distribution center for dietary supplement products (i.e., CHO WA Tea, COMOXIN IBS Formula or NEMURI Sleep Formula) that your firm distributes under your own name. We understand that you receive these products for packaging and labeling from the manufacturer, (b)(4). We understand that you perform some labeling operations and contract with the firm (b)(4) to perform packaging and labeling operations on your behalf for these products that you then distribute under your own name. We note that, to the extent you receive these products from, (b)(4) as a supplier (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f).
Moreover, to the extent that you contract with (b)(4) to manufacture your product, and/or contract with, (b)(4) to package and/or label product on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 331(a)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105).
Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement [21 CFR 111.127(h) and 111.140(b)(2)].
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.
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 reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your reply should be sent to the following address:
Dan Solis, Director
Import Operations Branch
U.S. Food and Drug Administration
Los Angeles District
1 World Trade Center, Suite 300
Long Beach, CA 90831
If you have questions regarding this letter, please contact Dr. Teresa T. Cain, Compliance Officer, at (562) 256-9248, or via e-mail to Teresa.Cain@fda.hhs.gov
CDR Steven E. Porter, Jr.
Los Angeles District Director