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  5. Enclara Pharmacia Inc - 513262 - 01/19/2018
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CLOSEOUT LETTER

Enclara Pharmacia Inc MARCS-CMS 513262 —

Recipient:
Enclara Pharmacia Inc

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd FL
Parsippany, NJ 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969 
 
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

January 19, 2018

John R. Loxterman
Vice President, Chief Compliance Officer
Enclara Pharmacia, Inc.
512 Elmwood Avenue
Sharon Hill, PA 19079-1014

Dear Mr. Loxterman:

This letter acknowledges receipt of your letter dated April 11, 2017, in which you responded to FDA’s warning letter (ref: WL# 17-PHI-09) dated March 29, 2017. We acknowledge your statement that your firm no longer produces sterile drug products. Therefore, it appears that you have adequately addressed the violations contained in this warning letter.

We note that in your response you stated that the warning letter alleged that your facility was deficient with regards to current good manufacturing practice (CGMP) requirements. As our letter states, the conditions observed during our inspection and described in the warning letter are violations of section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act. Regardless of whether your firm meets the conditions of section 503A and qualifies for the exemption from compliance with CGMP requirements, drug products prepared, packed, or held under insanitary conditions are adulterated. For additional information on insanitary conditions, we direct you to our draft guidance, Insanitary Conditions at Compounding Facilities, at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM514666.pdf. This guidance, if finalized, would provide additional guidance to pharmacies and State regulatory agencies in identifying insanitary conditions in compounding facilities.

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/

Yvette Johnson
Compliance Officer – PHRM1- CB

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