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CLOSEOUT LETTER

LEC Custom Products, Inc. MARCS-CMS 607838 —

Reference #:
FEI 3004737602
Product:
Drugs
Recipient:
Recipient Name
Mr. Jeremy Willard
Recipient Title
President & CEO
LEC Custom Products, Inc.

7 Kenview Boulevard
Brampton ON L6T 5G5
Canada

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Secondary Issuing Offices

United States

Dear Mr. Willard:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s remediation in response to our Warning Letter 320-20-47 dated September 24, 2020. Based on our evaluation, it appears that you have addressed the matter by no longer manufacturing drugs.

While the available information indicates that you no longer manufacture human drugs, your corrective actions do not involve coming into compliance with Current Good Manufacturing Practice (CGMP) requirements by manufacturing human drugs in accordance with CGMP requirements. Therefore, FDA has not had the opportunity to verify, via onsite inspection, CGMP compliance. While we consider this matter closed, note that if and when you resume the manufacturing of human drugs in the future, any human drugs you manufacture will be subject to the requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and failure to manufacture human drugs in accordance with CGMP requirements would cause those drugs to be adulterated.

Adulterated drugs are subject to refusal of admission into the United States under section 801(a)(3) of the FD&C Act. In addition, the receipt in interstate commerce of adulterated drugs and delivery or proffered delivery thereof for pay or otherwise is a violation of section 301(c) of the FD&C Act.

In addition, all applicable requirements of the FD&C Act would apply to any human drugs you manufacture in the future. Also, if you resume drug manufacturing activities, you will be required to register with FDA as a drug establishment. Notify us if this occurs.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the FD&C Act and its implementing regulations or with other relevant legal authority.

The FDA expects you and your firm to maintain compliance and will continue to monitor your compliance status. This letter will not preclude any future regulatory action if violations are observed during a subsequent inspection or through other means.

If you have any questions regarding this letter, contact CDER-OC-OMQ-Communications@fda.hhs.gov ATTN: Kevin Maguire


Sincerely,
/s/
Milind Ganjawala
Acting Director
Division of Drug Quality III
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

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