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  5. Gipsco Investment Corporation dba Lee Silsby Compounding Pharmacy - 557802 - 01/05/2023
  1. Warning Letters

CLOSEOUT LETTER

Gipsco Investment Corporation dba Lee Silsby Compounding Pharmacy MARCS-CMS 557802 —

Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Adam Israel
Recipient Title
CEO
Gipsco Investment Corporation dba Lee Silsby Compounding Pharmacy

23865 Mercantile Rd
Beachwood, OH 44122-5907
United States

adam@leesilsby.com
Issuing Office:
Detroit District Office

United States

Dear Mr. Israel:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (Case #557802), dated July 10, 2018. 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 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/
Nicholas F. Lyons
Director, Compliance Branch
Division of Pharmaceutical Quality Operations III

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