NEWS & EVENTS
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
Meet PYRAMID Professionals at These Upcoming Events:
- BIO INTERNATIONAL – June 6-9, 2016 (San Francisco, CA)
- TIDES – May 9-12, 2016 (Long Beach, CA)
- CONTRACT PHARMA – September 17, 2015 (New Brunswick, NJ)
- BIO INTERNATIONAL – June 15-18, 2015 (Philadelphia, PA)
Drug Development EXECUTIVE INTERVIEW – PYRAMID: Prescription for Building Success Through Partnerships. Quality. Integrity. Performance. These words may best describe the foundation upon which PYRAMID was built when it was founded in 1988 as an analytical services and method development company. This foundation has grown ever stronger throughout the past 28 years as it has transitioned from a 600-sq-ft laboratory into a 70,000-sq-ft commercial manufacturing facility with the expertise and flexibility to provide analytical, development, and small- and large-scale aseptic manufacturing and filling services to small start-up biotechs, big pharmas, and everyone in between. Drug Development & Delivery recently spoke with Medhat Gorgy, President and CEO of PYRAMID Laboratories, Inc., to discuss his success in building futures with his clients and more importantly, the lessons he’s learned along the way. more>>
Sep. 2, 2016
PYRAMID Laboratories, Inc., – Complete Another Successful FDA Inspection (PR Newswire). PYRAMID’s manufacturing services include formulation, processing, and filling capabilities for both vial and syringe applications. more>>
June 16, 2016
PYRAMID Laboratories, Inc., Complete Successful FDA Inspection (PR Newswire) 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. more>>
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Oscar R. Rebolledo, Ph.D.; Technical Sales-Business Development at DAISO Fine Chem USA,was the winner in our drawing for the iPad mini at the TIDES conference held last week in Boston. Oscar is pictured below with PYRAMID CEO Medhat Gorgy. more>>
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Medhat Gorgy, President and CEO PYRAMID LABORATORIES @BIO International 2013 (DAY 2) watch>>
April 22, 2013
Medhat Gorgy, President and CEO PYRAMID LABORATORIES @BIO International 2013 (DAY 1) watch>>
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Pharmaceutical Outsourcing – An Interview with Medhat Gorgy President & CEO PYRAMID Laboratories, Inc. more>>
May 6, 2009
U.S. Small Business Administration Names Medhat Gorgy Small Business Person Of The Year
Medhat Gorgy, President and CEO of PYRAMID Laboratories, Inc.(PLI) has been named the Small Business Person of the Year 2009 by the U.S. Small Business Administration, Santa Ana District Office. The district serves the counties of Orange, Riverside and San Bernardino. more>>