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CLOSEOUT LETTER

Legacy Pharmaceutical Packaging LLC MARCS-CMS 633735 —

Reference #:
FEI 3004453700
Product:
Drugs
Recipient:
Recipient Name
Mr. Bradley M. Rayner
Recipient Title
President
Legacy Pharmaceutical Packaging LLC

13333 Lakefront Dr.
Earth City, MO 63045
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

United States

Secondary Issuing Offices

United States

Dear Mr. Rayner:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #633735 dated October 3, 2022.

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/
Frank Wackes
Compliance Officer
Division of Drug Quality II

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