PYRAMID Laboratories Inc., Completes Successful FDA Inspection
FDA PAI & cGMP Inspection With No Observations.
Costa Mesa, CA / - 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 twelve day cGMP audit of its manufacturing and laboratory facilities.
Medhat S. Gorgy , CEO and Founder of PYRAMID Laboratories commented, "Completing a more than 2 week audit without 483s 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 trust PYRAMID to provide the highest quality standards and service for their drug product development and manufacturing requirements."
On Monday, May 16, 2016 through Wednesday, June 1, 2016, the FDA conducted a Pre-Approval and cGMP Inspection at PYRAMID’s facilities. PYRAMID Laboratories, Inc. is pleased to announce that the FDA did not issue a Form 483.The FDA performed a comprehensive audit; reviewing data from areas such as aseptic manufacturing, analytical development, analytical quality control and stability testing.
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's newest service addition is 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
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