Successful Inspection by the FDA of ENCO Pharmaceutical Development's Cary, NC Facility
JACKSONVILLE, Fla., Feb. 19, 2013 /PRNewswire-iReach/ -- ENCO Pharmaceutical Development, Inc. (EPDI) is pleased to announce the completion of a successful FDA inspection of its Cary, NC facility. The 3-day audit included both a general cGMP inspection as well as a directed Pre-approval Inspection (PAI). This was the first FDA audit of EPDI's Cary facility which opened in 2010.
"We have worked hard over the years to ensure that our quality systems are robust and to foster an atmosphere of compliance within our organization," said Rick Camp, President of EPDI. Christopher Walker, who manages the Cary facility commented, "It is gratifying to have completed this very thorough audit by the FDA so successfully, particularly since this is a new site for EPDI."
The audit covered thorough reviews of general systems and documentation such as SOP's, test methods and protocols and involved a variety of technical areas including analytical development, release and stability testing and storage.
Upon completion of the inspection, the investigator reported no findings and no Form 483 was issued.
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.
SOURCE ENCO Pharmaceutical Development, Inc.