FDA Letter API

The Elderberry Fairy & Co., LLC

Letter data

Company
The Elderberry Fairy & Co., LLC
Recipient
Catie Fasno | Owner | The Elderberry Fairy & Co., LLC | 3320 Electric Avenue | Lincoln Park | , | MI | 48146 | United States
Issue date
2023-04-26
Posted date
Not available
FDA office
Office of Human and Animal Food Operations East Division 6
Subject
Not available
Product
Dietary Supplements
CMS ID
622859
Reference number
Not available
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: None found

21 U.S.C.: None found

Related FDA links

No related FDA letter link is present in the source index.

Full source text

CLOSEOUT LETTER The Elderberry Fairy & Co., LLC MARCS-CMS 622859 — April 26, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Catie Fasno Recipient Title Owner The Elderberry Fairy & Co., LLC 3320 Electric Avenue Lincoln Park , MI 48146 United States Issuing Office: Office of Human and Animal Food Operations East Division 6 United States Dear Ms. Fasno: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY2022-HAFE6-WL-08. Based on our evaluation, it appears that you have addressed the violation(s) contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ LCDR Kelli L. Wilkinson Compliance Branch Director Content current as of: 04/28/2023 Regulated Product(s) Dietary Supplements