CLOSEOUT LETTER
Walter's Pharmacy, Inc. MARCS-CMS 506596 —
- Recipient:
- Walter's Pharmacy, Inc.
United States
- Issuing Office:
United States
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Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd FL Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973) 331-4969 |
Wednesday, May 9, 2018
Mr. Howard Anthony, Owner
Walter’s Pharmacy, Inc.
401 N 17th St
Allentown, PA 18104-5034
Dear Mr. Anthony:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (17-PHI-03; CMS # 506596) issued on January 11, 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. If you decide to resume production of drug products intended to be sterile, FDA strongly recommends that you undertake a comprehensive assessment of your operations, including facility design, and that you notify FDA prior to resuming sterile production. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Diana Amador Toro
Division Director/OPQ Division 1
New Jersey District Office