2014

ENCO Pharmaceutical Development Announces Another Successful FDA Inspection - Its 2nd This Year

JACKSONVILLE, Fla., March 20, 2013 /PRNewswire-iReach/ --  ENCO Pharmaceutical Development's Jacksonville, FL Facility Completes Successful FDA Audit

ENCO Pharmaceutical Development, Inc. (EPDI) is pleased to announce the completion of a successful FDA inspection of its Jacksonville FL facility.  The audit was a directed Pre-approval Inspection (PAI). 

The audit occurred between March 7th and 8th, 2013.  Upon the completion of the inspection, the investigator reported no findings and no Form 483 was issued.

"As a company we understand the value of maintaining a high level of compliance," said Mark Inman, Ph.D., VP and Director of Quality Assurance.  "Not only do we want to ensure adherence to the existing regulatory requirements, EPDI also remains connected to the various regulatory bodies we work with to keep the company at the forefront of changes in the regulatory industry."

This audit marks the second consecutive month that an EPDI facility has been audited by the FDA.  In February, auditors inspected EPDI's Cary, NC facility.  "Between the two audits, our company has experienced nearly 5 days of intensive inspection by the FDA with no 483's or observations to report," Mark Inman continued. 

The audit covered thorough reviews of general systems such as training, equipment calibration/qualification, SOP's, protocols and methods and involved a variety of technical areas including analytical development and release testing.

ENCO Pharmaceutical Development Inc. provides a broad spectrum of pharmaceutical development and analytical services from its facilities in Jacksonville, FL and Cary, NC.  The company works with a variety of organizations in both the pharmaceutical and medical device industries, including global, small and mid-size firms, as well as virtual organizations. EPDI provides expertise in formulation development of solid, semi-solid, liquids, ophthalmic and lyophilized dosage forms as well as analytical support for method development and validation, stability studies, raw materials testing, extractable/leachable studies, medical device testing and more. For additional information, please visit www.encopharma.com.

Media Contact: Keith Hurley, ENCO Pharmaceutical Development, Inc., 336.541.3270, khurley@encopharma.com

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SOURCE ENCO Pharmaceutical Development, Inc.



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