Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc.

Warning LetterOpen

Jack H. Gindi Owner Flawless Beauty and Skin 1750 Brielle Ave, Suites A3, A4, and A6 Ocean , NJ 07712 United StatesFEI 3001237063Issued Aug 5, 2022Office of Human and Animal Food Operations – West Division 6

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3001237063.

Letter Details

Firm: Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc.
Location: Jack H. Gindi Owner Flawless Beauty and Skin 1750 Brielle Ave, Suites A3, A4, and A6 Ocean , NJ 07712 United States
FEI Number: 3001237063
Country: United States
Issue Date: August 05, 2022
Issuing Office: Office of Human and Animal Food Operations – West Division 6
Product Type: Dietary Supplements
Status: Open

Summary

Nutritional Laboratories International, Inc. (doing business as Elite One Source Nutritional Services, Inc. and Flawless Beauty and Skin) was cited for importing and distributing medical devices including derma pens, dermastampers, and dermarollers without required FDA approvals or clearances. The company failed to comply with medical device regulations by marketing products intended to treat or affect body structure or function without the necessary premarket authorization, and the products were deemed adulterated under the Federal Food, Drug, and Cosmetic Act. An FDA inspection conducted between November 2021 and January 2022 identified these violations based on evidence from product packaging, labels, user manuals, brochures, and website marketing materials.

Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc. FDA Warning Letter, August 5, 2022