Navigation Links
Successful Inspection by the FDA of ENCO Pharmaceutical Development's Cary, NC Facility
Date:2/19/2013

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.

Media Contact: Keith Hurley , ENCO Pharmaceutical Development, Inc.,336-541-3270, khurley@encopharma.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE ENCO Pharmaceutical Development, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Imprimis Announces Successful Results from its Pharmacokinetic Study for its Impracor Topical NSAID
2. Columbia Asia Referral Hospital, Yeshwanthpur, Successfully Conducts HOLEP to Treat a 72-Year-old With Urology Disorder
3. Coyote Pharmaceuticals Initiates GMP Manufacturing Process for CNS-102 Following Successful Pre-IND Meeting
4. Kemwell Announces Successful Pre-NDA US FDA Inspection
5. New Study Introduces Valuable Tool to Aid Doctors and Patients in Choosing Successful Outcomes for Cheek Rejuvenation
6. Braincells, Inc. Announces the Successful Completion of a Multiple Ascending Dose Study of BCI-838, a Group II mGluR2/3 Antagonist, and the Companys Plans for a Proof-of-Concept Study in Patients with Treatment-Resistant Depression
7. Easy on the Stomach: ALCAT Worldwide Sponsors Successful Conference on Gut, Brain & Autoimmune Disorders
8. Omeros Ophthalmology Product OMS302 Successful in Second Phase 3 Clinical Trial
9. A Successful Launch of a New Oncology Product Requires Global Teams & Planning
10. Novelos Therapeutics Successfully Completes Second Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT) Cancer-Targeted Molecular Radiotherapeutic
11. Report Highlights Key Activities that Drive Successful New Product Planning Groups in Pharmaceutical Industry
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 ... Markets has announced the addition of the " ... offering. This ... and provides an updated review, including its applications in ... the total market, which includes three main industries: pharmaceutical ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from PsychTests.com reveals that ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Those who ... with these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, ... Marne, Michigan, has released tools for healthy coping following a traumatic event. , Trauma ...
Breaking Medicine News(10 mins):