In the medical device industry, FDA regulation is a crucial aspect of ensuring product safety and efficacy. Pingchuang Medical, as a professional OEM/ODM manufacturer of personal lubricants, showcases its ability to handle FDA surprise inspections through its collaboration with North America’s top 3 brands.
Pingchuang Medical’s preparation for FDA surprise inspections begins with product registration and certification. Our professional team strictly adheres to FDA requirements during the product development phase, ensuring that every batch of products meets safety and efficacy standards. Our lubricant products have obtained FDA 510K certification, ensuring market access in multiple countries.
Before surprise inspections, Pingchuang Medical conducts comprehensive self-checks of production processes to ensure every aspect complies with GMP standards. Our production base features a 100,000-level cleanroom, ensuring that the production environment meets international standards. Every employee must undergo strict disinfection procedures before entering the cleanroom to maintain a controlled production environment.
During surprise inspections, Pingchuang Medical’s quality control team accompanies the inspectors to ensure the inspection proceeds smoothly. Our professional team promptly provides the necessary technical documentation and testing reports, ensuring that inspectors have a thorough understanding of the product’s safety and efficacy. Through such preparations, we can effectively respond to FDA surprise inspections and ensure products pass audits smoothly.
Pingchuang Medical’s lubricant products have obtained FDA 510K and CE certifications, ensuring market access in multiple countries. We always adhere to a customer-centric approach, continuously enhancing product quality and service levels. Through our professional services, clients can quickly establish themselves in a competitive market and achieve brand success.
