U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Calvin Scott & Company, Inc. - 606987 - 08/04/2023
  1. Warning Letters

CLOSEOUT LETTER

Calvin Scott & Company, Inc. MARCS-CMS 606987 —

Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Jan-Erik Palm
Recipient Title
President
Calvin Scott & Company, Inc.

209 Eubank Blvd NE
Albuquerque, NM 87123
United States

jepalm@calvinscottinc.com
Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States

Dear Mr. Palm: 

The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL #606987) dated August 25, 2020. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. 

You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and the FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. 


Sincerely, 
/S/
CDR Steven E. Porter, Jr. 
Director, Division of Pharmaceutical Quality Operations IV

Back to Top