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  5. Jack P. Herick, Inc. dba Glades Drugs - Close Out Letter 4/21/17
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CLOSEOUT LETTER

Jack P. Herick, Inc. dba Glades Drugs


Jack P. Herick, Inc. dba Glades Drugs

 

  

Black HHS-Blue FDA Logo

 

 

 
Florida District Office
555 Winderley Place, Suite 200
Maitland, Florida 32751 

VIA UPS NEXT DAY AIR
w/DELIVERY CONFIRMATION

April 21, 2017
 

Ryan Goodkin, Co-Owner
Jack P. Herick, Inc., dba Glades Drugs
109 S. Lake Avenue
Pahokee, FL 33476-1803

Dear Mr. Goodkin:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to the warning letter (ref: WL# FL-16-22) to your firm on August 9, 2016. We acknowledge that you have implemented new standard operating procedures related to compounding, including compounding from bulk drug substances, and that you have also begun random testing of your compounded products. Based on our evaluation, it appears that you have addressed the violations contained in the warning letter.

You are expected to take all necessary steps to assure 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/
Susan M. Turcovski
Director, Florida District