VapeCentric, Inc.
Letter data
- Company
- VapeCentric, Inc.
- Recipient
- Michael Daneshrad | VapeCentric, Inc. | 30101 Agoura Court | Suite 233 | Agoura Hills | , | CA | 91301 | United States | sales@vapecentric.com | mike@vapecentric.com
- Issue date
- 2020-11-20
- Posted date
- Not available
- FDA office
- Office of Compliance and Enforcement
- Subject
- Not available
- Product
- Not available
- CMS ID
- 607375
- Reference number
- RW2001268
- FEI
- Not available
- Inspection dates
- 2020-05-18 to 2020-09-27
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
VapeCentric, Inc.
MARCS-CMS 607375 —
November 20, 2020
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Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001268
Recipient:
Recipient Name
Michael Daneshrad
VapeCentric, Inc.
30101 Agoura Court
Suite 233
Agoura Hills
,
CA
91301
United States
sales@vapecentric.com
mike@vapecentric.com
Issuing Office:
Office of Compliance and Enforcement
United States
Dear Michael Daneshrad:
On April 27, 2020, the Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) issued a Warning Letter informing you that your e-liquid product (e.g. Pink Sticks) was adulterated under section 902(6)(A) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting this product was not provided as required by section 905(j) of the FD&C Act. In addition, a conference call was held between FDA and VapeCentric, Inc. (VapeCentric) on August 17, 2020.
On May 18, 2020 and September 27, 2020, FDA received response letters from Phil Daman, Esq. at Daman & Associates, LLP on behalf of VapeCentric, representing that corrective actions were taken to address the violation identified in the Warning Letter and related concerns.
Based upon our evaluation, it appears the stated corrections have been made.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure compliance with the FD&C Act and its implementing regulations or other relevant legal authority. This letter will not preclude regulatory action should violations be observed in the future.
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at
(301) 796-9235
or via email at
CTPCompliance@fda.hhs.gov
.
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
Michael Daneshrad
5015 Blackpool Avenue
Oak Park, CA 91377
Phil Daman, Esq.
369 Lexington Ave., 3rd Floor
New York, NY 10017
phillip.daman@damanllp.com
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Content current as of:
12/01/2020