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FDA INSPECTION OF ENTACO/REDDITCH MEDICAL

Redditch Medical is the preferred supplier of manufacturing services for the medical device industry. To support our customers, Redditch Medical has employed the latest quality techniques and current Good Manufacturing Practice to ensure that regulatory requirements are achieved and maintained. With consistent commitment to quality, for many years Redditch Medical has held approvals for ISO 13485, ISO 9001 and the FDA’s Quality System Regulations.

In recent weeks Redditch Medical’s device division was subject to a US FDA Inspection, performed against the Quality System Regulations (QSR) for medical devices, Title 21 Code of Federal Regulations (CFR) Part 820. The FDA Inspection of the Redditch Medical site, in Redditch Worcestershire, was successfully undertaken demonstrating our continued support of products sold into the US marketplace.

Redditch Medical has been working to enhance the Quality Management System to achieve the highest quality standards and compliance against the latest industry regulations. At the point the FDA inspection was confirmed, Redditch Medical’s experienced team developed and implemented a quality plan to finalise critical objectives to guarantee a successful outcome from the four day inspection.

The management team commented ‘The FDA inspection has generated a wealth of experience for Redditch Medical. As a subcontractor to the medical device industry we can continue to offer a unique service to our customers and provide first-hand experience of the latest strategies, quality techniques and manufacturing controls. The successful outcome from the most recent FDA inspection is a testament to the expertise, hard work and discipline of the Redditch Medical team. Every challenge was welcomed with a proactive approach and the organisation has achieved its ultimate aim. We now look forward to future targets, maintaining objectives and defining new ways to offer an optimum service to our customer base’.