Eden’s Answers, Inc.

Warning LetterOpen

Jonathan Laudon Owner Eden’s Answers, Inc. 1701 N. 14th St., Suite A Tampa , FL 33605 United StatesFEI 3012343370Issued Jun 28, 2023Division of Human and Animal Food Operations East V

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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 3012343370.

Violations6

Issue DateJun 28, 2023

Product TypeDietary Supplements

StatusOpen

Letter Details

Firm: Eden’s Answers, Inc.
Location: Jonathan Laudon Owner Eden’s Answers, Inc. 1701 N. 14th St., Suite A Tampa , FL 33605 United States
FEI Number: 3012343370
Country: United States
Issue Date: June 28, 2023
Issuing Office: Division of Human and Animal Food Operations East V
Product Type: Dietary Supplements
Status: Open

Summary

Eden's Answers, Inc. was cited for serious Current Good Manufacturing Practice (CGMP) violations in the production of dietary supplements, including Dental Health, Honey Herbal Syrup, and Lil' Ones Sleepy Time, rendering these products adulterated. The company failed to establish proper identity specifications for components used in manufacturing and did not create adequate specifications for finished product identity, purity, strength, and composition, in violation of 21 CFR Part 111. The violations were identified during an FDA inspection of the Holmesville, Ohio facility conducted from August through November 2022, and the company submitted multiple responses between November 2022 and May 2023 that were reviewed and found inadequate.

Eden’s Answers, Inc. FDA Warning Letter, June 28, 2023