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# Hygienic Labs Didn’t Respond to FDA Data Requests
- URL: https://www.fdaweb.com/hygienic-labs-didnt-respond-to-fda-data-requests/
- Published: 2023-10-19T12:00:00.000Z
- Updated: 2026-09-14T14:13:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155606

FDA says Hygienic Labs in Denver, CO, a manufacturer of over-the-counter (OTC) drug products, has not responded to several agency requests for records and other information. In a just-released 9/19 Warning Letter, the agency says it is unlawful to refuse to permit access to or copying of any record as required by law.

“Because your OTC drug firm failed to respond to the … records request and associated communications attempts,” the letter says, “we have no indication of quality assurance for drugs registered as manufactured at your facility. Respond to this letter within 48 hours to confirm or update your registration and/or drug listing status and indicate whether you will respond to the request for records and other information.”

FDA says that if Hygienic Labs is no longer manufacturing drugs, it should delist all the drugs previously listed with FDA, using the last expiration date as the marketing end date of the product, and deregister its facility accordingly.