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  5. Missouri Analytical Laboratories Inc - 615319 - 10/09/2024
  1. Warning Letters

CLOSEOUT LETTER

Missouri Analytical Laboratories Inc MARCS-CMS 615319 —

Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Mr. Richard A. Gilbert
Recipient Title
President
Missouri Analytical Laboratories Inc

1820 Delmar Boulevard
Saint Louis, MO 63103
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

United States

Secondary Issuing Offices

United States

Dear Mr. Gilbert:

The Food and Drug Administration has completed the evaluation of corrective actions in response to our Warning Letter (WL # 615319), dated September 30, 2021.

Based on our evaluation, it appears that you have addressed the violations 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.

The FDA 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/
Brian Nicholson
Compliance Officer
Division of Drug Quality I

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