- Delivery Method:
- UPS Next Day
Recipient NameCarey Jaros
Recipient TitlePresident & CEO
- GOJO Industries Inc
3783 State Road
Cuyahoga Falls, OH 44223-2603
- Issuing Office:
- Division of Pharmaceutical Quality Operations III
- (313) 393-8100
Dear Ms. Jaros:
The Food and Drug Administration has reviewed requests made by your legal counsel regarding a close-out letter for the corrective actions your firm made in response to our Warning Letter #599132 issued January 17, 2020. We acknowledge your February 7, 2020, February 26, 2020, and June 5, 2020 letters that detail the corrective actions that GOJO Industries represents it has initiated, as well as those that are planned, to prevent a reoccurrence of the violations noted in the Warning Letter. As a reminder, the January 17, 2020 Warning Letter did not document an all-inclusive list of violations nor did it cite an all-inclusive list of claims that demonstrate your products’ intended uses. Rather, the cited claims were merely examples. And as we have stated, it is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
As stated in our July 9, 2020 correspondence to you, FDA’s Regulatory Procedures Manual1 (RPM) states a close-out letter will not be issued based on representations that some action will or has been taken. The corrective actions must actually have been made and verified by FDA. Since FDA is unable to verify the entirety of your corrective actions, a close-out letter will not be issued.
Please note that FDA is currently issuing Warning Letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19), see https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products. As noted on that website, an Asterix under the table column "Corrective Status” indicates that the firm’s listed product(s) are no longer sold for the prevention, treatment, mitigation, diagnosis or cure of coronavirus disease 2019 (COVID-19). This status only concerns the sale of the listed product(s) for the prevention, treatment, mitigation, diagnosis or cure of coronavirus disease 2019 (COVID-19) and in no way indicates whether the listed products otherwise comply with the laws and regulations enforced by FDA. Furthermore, an Asterix is not a close out letter nor does an Asterix mean that a firm will receive a close out letter that would appear on the website, https://www.fda.gov/inspectionscompliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters.
In regards to our interactions with firms listed on the aforementioned fraudulent COVID-19 product website, please note that it is FDA’s policy to not discuss the specific regulatory status of products or potential, pending, or ongoing investigations and actions except with the firm and individuals who are responsible for such products.
In addition, this letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during subsequent surveillance activities or through other means.
Please let me know if you have any additional comments or questions.
Nicholas F. Lyons
Director of Compliance
Office of Pharmaceutical Quality Operations, Division III
(312) 596-4220 / Nicholas.firstname.lastname@example.org
David J. Horowitz
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington, DC 20004
- 1. Regulatory Procedures Manual, March 2020, Chap. 4, § 4-1-8, at 15-16, available at https://www.fda.gov/media/71878/download