Gipsco Investment Corporation dba Lee Silsby Compounding Pharmacy MARCS-CMS 557802 —
- Delivery Method:
- UPS Next Day
Recipient NameAdam Israel
- Gipsco Investment Corporation dba Lee Silsby Compounding Pharmacy
23865 Mercantile Rd
Beachwood, OH 44122-5907
- Issuing Office:
- Detroit District Office
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.
Nicholas F. Lyons
Director, Compliance Branch
Division of Pharmaceutical Quality Operations III