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The company announced that an August 2016 FDA inspection of the company’s facility resulted in no form 483s.
PYRAMID Laboratories Inc. announced on Sept. 2, 2016 that the company had successfully passed an unannounced FDA inspection of the company’s manufacturing and laboratory facilities conducted on Aug. 30–31, 2016. The inspection, which was supposed to last four days, included an evaluation of the company’s regulatory submissions, operational processes, and procedures regarding the utilities, manufacturing process, batch records, equipment validation, training records, material handling, and reporting and records management systems. According to the company, no FDA 483s were issued.
"Completing a four-day inspection in only two 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," Medhat S. Gorgy, CEO and founder of PYRAMID Laboratories stated in the press release.
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. PYRAMID's manufacturing services include formulation, processing, and filling capabilities for both vial and syringe applications.
Source: PYRAMID Laboratories