KSE Scientific is a specialized bioprocess manufacturer that focuses on producing high-quality products tailored for the Tissue Banking, Pharmaceutical, and Biotech industries. The company operates within a facility that adheres to stringent standards, including ISO 13485:2015 certification, Good Manufacturing Practices (GMP) compliance, and FDA registration. This commitment to quality ensures that all products are manufactured according to the exact specifications of their customers, highlighting KSE Scientific's dedication to maintaining high standards in bioprocess manufacturing.

Recently, KSE Scientific initiated a nationwide recall of certain products due to non-compliance with current good manufacturing practices (cGMP). The recall was prompted by identified gaps in the company's quality management system and documentation, which raised concerns about the products meeting all necessary specifications. While there have been no reported adverse events associated with the recalled items, the company has urged customers to stop using the affected products and return them for replacement or disposal. This proactive approach underscores KSE Scientific's commitment to safety and quality assurance in its operations.

United States

KSE Scientific is a Bioprocess manufacturer specializing in the production of sterile products for the Tissue Banking, Pharmaceutical, and Biotech industries.

KSE Scientific

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