Hygienic Labs, LLC

Warning LetterOpen

Neil Sargisian Hygienic Labs, LLC 909 Bannock Street, Suite 609 Denver , CO 80204 United StatesFEI 3017242852Issued Sep 19, 2023Center for Drug Evaluation and Research | CDER

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Violations1

Issue DateSep 19, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: Hygienic Labs, LLC
Location: Neil Sargisian Hygienic Labs, LLC 909 Bannock Street, Suite 609 Denver , CO 80204 United States
FEI Number: 3017242852
Country: United States
Issue Date: September 19, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

Hygienic Labs, LLC, a manufacturer of over-the-counter drug products, was cited for refusing to provide access to and copying of records in violation of section 301(e) of the Federal Food, Drug, and Cosmetic Act. The company failed to respond to three separate records requests issued pursuant to section 704(a)(4) between September 2022 and February 2023, including electronic requests, phone contact attempts, and a written request delivered via UPS to its registered address. Due to the company's non-compliance, the FDA had no ability to assess the quality assurance standards for drugs manufactured at the facility. The firm was directed to respond within 48 hours to confirm its registration status and indicate whether it would comply with the outstanding records request.

Hygienic Labs, LLC FDA Warning Letter, September 19, 2023