Hygienic Labs, LLC – FDA Warning Letter, Oct 17, 2023

This FDA Warning Letter, dated September 19, 2023, addresses an OTC drug manufacturer registered with the FDA. The firm, located at 909 Bannock Street, Suite 609, Denver, CO 80204, failed to respond to multiple requests for records and information under section 704(a)(4) of the FD&C Act.

The FDA initiated an electronic request on September 27, 2022, followed by a second email on October 12, 2022. Subsequent attempts to contact the firm by phone on December 8 and 14, 2022, were unsuccessful. A written request sent via UPS was delivered on February 7, 2023, but also received no response. A final phone attempt on September 15, 2023, indicated the provided number was out of service.

The failure to permit access to or copying of records as required by section 704(a) constitutes a prohibited act under section 301(e) of the FD&C Act. Due to the firm's unresponsiveness, the FDA has no indication of the quality assurance level for drugs manufactured at the facility.

The firm is required to respond within 48 hours to confirm or update its registration and/or drug listing status and indicate whether it will respond to the records request.