The successful completion of an FDA inspection represents a key milestone for CS Analytical and is a testament to our unwavering dedication to state-of-the-art quality, a strong focus on continuous improvement and the team's diligence in ensuring the highest standards of safety and efficacy in all aspects of our operation.
CLIFTON, N.J., Feb. 28, 2024 /PRNewswire-PRWeb/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and testing services specifically for drug product and medical device package systems, is excited to announce that between January 9, 2024 and January 23rd, its laboratory was subject to an onsite, FDA inspection for compliance to GMP guidelines that resulted in no observations being noted.
"The successful completion of an FDA inspection represents a key milestone for CS Analytical and is a testament to our unwavering dedication to state-of-the-art quality, a strong focus on continuous improvement and the team's diligence in ensuring the highest standards of safety and efficacy in all aspects of our operation," noted Director of Quality Sandra Cincotta.
Added CEO Brian Mulhall, "Under the direction of Ms. Cincotta, our team adheres to a relentless focus on quality and regulatory compliance in all aspects of our operation which is key to ensuring we are always meeting or exceeding client expectations when it comes to providing critical qualification testing services."
In today's environment of a risked-based approach to quality, Good Manufacturing Practice (GMP) regulations and industry guidance all describe the criticality of implementing a structured approach to quality conformance that ensures drug and medical device products that come to market are safe and efficacious. The FDA inspection process is designed to ensure that these principles are maintained to exacting standards. Companies such as CS Analytical are expected to be compliant and in a continual state of improvement. Closing out an FDA inspection with no observations indicates that the company's programs, processes, and procedures are meeting the regulatory requirements.
About CS Analytical Laboratory
The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world's leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP 1207 services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.
Media Contact
Brian Mulhall, CS Analytical, 1-888-571-1207, [email protected], https://csanalytical.com/
SOURCE CS Analytical
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