NatureLab Corp.
Letter data
- Company
- NatureLab Corp.
- Recipient
- Charles B. Shea | President | NatureLab Corp. | 1606 Vantage Dr. | Carrollton | , | TX | 75006-5613 | United States
- Issue date
- 2023-04-25
- Posted date
- Not available
- FDA office
- Division of Pharmaceutical Quality Operations II
- Subject
- Not available
- Product
- Dietary Supplements
- CMS ID
- 625768
- 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
NatureLab Corp.
MARCS-CMS 625768 —
April 25, 2023
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Delivery Method:
UPS Overnight
Product:
Dietary Supplements
Recipient:
Recipient Name
Charles B. Shea
Recipient Title
President
NatureLab Corp.
1606 Vantage Dr.
Carrollton
,
TX
75006-5613
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
Dear Mr. Shea,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated July 12, 2022, issued following inspection of your facility located at 1606 Vantage Dr., Carrollton, TX 75006-5613. Based on our evaluation, it appears that you have addressed the violation(s) contained in this 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. If you choose to reestablish or sell your operations, 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/
Jessica E. Havranek
Director of Compliance
Office of Human and Animal Food, WD3
Content current as of:
04/28/2023
Regulated Product(s)
Dietary Supplements