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  5. Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy - 524550 - 04/22/2019
  1. Warning Letters

CLOSEOUT LETTER

Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy MARCS-CMS 524550 —

Product:
Drugs
Recipient:
Recipient Name
Christopher M. Schulte
Recipient Title
Owner
Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy

6506 N. Davis Highway
Pensacola, FL 32504-6957
United States

Issuing Office:
Center for Drug Evaluation and Research

United States

Mr. Schulte:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS Case #524550; June 28, 2017). We acknowledge that your firm no longer produces sterile drug products. 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 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.

If there is any question about this information, please contact Jose R. Lopez, Compliance Officer, at (787) 729-8603, or by email at JoseR.Lopez@fda.hhs.gov.

Sincerely,
/S/
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II

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