Warning Letter 320-24-07

December 21, 2023

Dear Mr. Chandran:

Your firm was registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products including hand sanitizers, specifically, Aiken Hand Sanitizer. A review of import records showed multiple shipments of OTC drug products into the United States which declared WIPRO Consumer Care Vietnam Company, Limited as the drug manufacturer.

On June 16, 2022, the FDA sent a request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request went unanswered. A second request was sent via e-mail on July 7, 2022, followed by a telephone conversation with your registered United States Agent on September 2, 2022, regarding this matter. The Agency sent a follow-up written request for such records and other information on October 7, 2022. Delivery to you was confirmed by the shipper, but you failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.

On October 10, 2022, your Head of Legal e-mailed FDA stating that “our hand sanitizer product is not exported” to the United States, “nor do we have any plans for distribution” in the United States. However, our import records showed your firm had shipped drug product to the United States. On May 4, 2023, FDA held a teleconference with you and your consultant, where you committed to collecting additional information regarding your firm’s registration with the FDA. Your consultant provided a letter to FDA, dated May 29, 2023, stating that your firm contracted directly with a distributor, specifically to register your firm with the FDA and distribute products to the United States market. This letter is in contrast to your Head of Legal’s original communication to FDA.

We acknowledge your registration with FDA expired on December 31, 2022, and your consultant communicated with the Agency that you would not ship drug products either directly or indirectly to the United States.

It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a). Because your OTC drug firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.

On July 5, 2023, FDA notified the public that you failed to respond to multiple FDA requests for records related to drug manufacturing and product quality, at the following website:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use

FDA also placed all drugs and drug products manufactured by your firm on Import Alert 66-79 on August 11, 2023.

Until FDA is able to confirm compliance with Current Good Manufacturing Practice (CGMP) and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at WIPRO Consumer Care Vietnam Company, Limited, FEI 3015596082 located at 7 Street No. 4, Viet Nam, Singapore Industrial Zone, Binh HOA Ward, Thuan An, Binh Duong Province, Vietnam into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).

After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3015596082 and ATTN: Yasamin Ameri.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

Cc:
Registered U.S. Agent:
Liberty Management Group, Ltd.
manoj@libertymanagement.us

Dnyanesh Sabnis, General Lead Counsel
dnyanesh.sabnis@wipro.com