PYRAMID Laboratories Inc., Completes Another Successful FDA Inspection

FDA PAI & cGMP Inspection With No Observations

COSTA MESA, Calif., Sept. 2, 2016 /PRNewswire-iReach/ -- PYRAMID Laboratories, Inc., a premier service provider of cGMP contract development and sterile manufacturing services for the pharmaceutical, biotech, and medical device industries is pleased to announce it successfully completed a 2 day cGMP audit of its manufacturing and laboratory facilities.

On Tuesday, August 30, 2016 through Wednesday, August 31, 2016, the FDA conducted an unannounced special Pre-Approval and cGMP Inspection at PYRAMID's facilities. The inspection was scheduled for four (4) days however, as a result of PYRAMID's readiness to receive the FDA and provide information in a timely, efficient manner the inspection duration was concluded in only two (2) days.

PYRAMID Laboratories, Inc. is pleased to announce that the FDA did not issue a Form 483. The FDA performed a comprehensive inspection and evaluated various regulatory submissions, operational processes and procedures regarding the utilities, manufacturing process, batch records, equipment validation, training records, material handling, reporting and records management systems.

Medhat S. Gorgy, CEO and Founder of PYRAMID Laboratories commented, "Completing a 4 day inspection in only 2 days without any observations and no Form 483 being issued underlines the strength of our quality systems and  employee training programs; especially during the time when  PYRAMID  has continued to  expanded our  expertise and capabilities for the past 28 years.  This allows our Clients to continue to trust PYRAMID to provide the highest quality standards and services for their drug product development and manufacturing requirements."

PYRAMID Laboratories, Inc., is an independent professional service organization specializing in contract manufacturing, analytical services, product development, formulation, fill/finish/ lyophilization and supporting laboratory services compliant with GLP and cGMP guidelines for all Phases of drug product development and supply; from preclinical toxicology batches to commercial launch and supply. PYRAMID also has a 27,000 sq. ft. temperature controlled warehouse & distribution center for parenteral products.

PYRAMID's manufacturing services include formulation, processing, and filling capabilities for both vial and syringe applications.

Learn more about PYRAMID at www.pyramidlabs.com  

 1988-2016 - Celebrating 28 Years of Quality, Performance & Integrity

Media Contact: Medhat Gorgy, PYRAMID, 714 435-9800, medhat@pyramidlabs.com

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SOURCE Pyramid Laboratories, Inc



2017

Tags

Biotechnology, Health Care & Hospitals, Pharmaceuticals, Corporate Expansion


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