Navigation Links
ENCO Pharmaceutical Development Announces Another Successful FDA Inspection - Its 2nd This Year
Date:3/20/2013

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

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. Report Presents a Framework for Successful New Oncology Product Launches in the Pharmaceutical Sector
2. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
3. Pharmaceutical Industry Service Company Awarded The UKs Most Prestigious Business Accolade in Recognition of Outstanding Achievement in International Trade
4. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
5. Simcere Pharmaceutical Group to Announce First Quarter 2012 Financial Results on Wednesday, May 9, 2012
6. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
7. Thomson Reuters Launches New Mobile Oncology Decision Support Solution for R&D Pharmaceutical Leaders
8. Amgen to Acquire Mustafa Nevzat, a Leading Privately Held Turkish Pharmaceutical Company
9. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
10. Icahn Issues Statement Regarding Amylin Pharmaceuticals
11. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/5/2017)... 2017  In response to the nationwide opioid ... Surgeons (AAOMS) released prescribing recommendations that urge ibuprofen ... as a first-line therapy to manage a patient,s ... Recognizing the value and importance of ... Prescribing: Acute and Postoperative Pain Management" stresses that ...
(Date:10/4/2017)... , Oct. 4, 2017 ... single-use, self-contained, illuminating medical devices, today announced regulatory ... Health Surveillance Agency (or Agência Nacional de Vigilância ... first single-use, cordless surgical retractor with integrated LED ... optimal access, illumination and exposure of a tissue ...
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, ... formed by Walgreens and pharmacy benefit manager Prime Therapeutics ... new brand, which included the unveiling of new signage ... , as well as at a few other company-owned ... new brand to patients, some of whom will begin ...
Breaking Medicine Technology:
(Date:10/13/2017)... Calif. (PRWEB) , ... October 13, 2017 , ... Many ... dementia. However, many long-term care insurance companies have a waiver for care if the ... 90-day elimination period, when the family pays for care, is often waived, so the ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids this ... by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited about ... ages; it is a non-competitive, non-timed event, which is all about having fun and ...
(Date:10/13/2017)... ... 13, 2017 , ... Coveros, a leader in agile coaching ... contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile ... of Agile methodologies in a consistent and high value manner across CMS programs. ...
(Date:10/12/2017)... ... 2017 , ... First Healthcare Compliance (FHC), an industry leader ... range of technology and learning solutions at the 68th Annual American Healthcare Association ... held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, Nevada. ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... the demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults ... tested to meet the highest standard. , These products are also: Gluten ...
Breaking Medicine News(10 mins):