BRIGHTWAKE LTD – FDA EIR, Aug 19, 2016

An FDA inspection was conducted at BRIGHTWAKE LTD on August 19, 2016, as a routine comprehensive Quality System Inspection Technique (QSIT) under C.P. 7382.845 for medical device manufacturers. The United Kingdom-based firm manufactures and contract manufactures sterile and non-sterile Class I and Class II medical devices. The inspection focused on Management Controls, a limited review of Corrective and Preventive Action (CAPA), and Production and Process Controls, particularly concerning the contract manufacturing of ConvaTec's Aquacel Ag Burn Dressing. Although no formal FDA 483 Inspectional Observations were issued, one verbal observation was discussed with management. The primary concern was the firm's practice of using a single CAPA form to document CAPA, non-conformities, and complaints. The FDA noted this approach could lead to inadequate complaint handling and investigations. Firm management acknowledged the observation and committed to making necessary corrections. Additionally, the firm was reminded of its ongoing responsibility to comply with all FDA regulations and to conduct internal self-audits to identify and rectify any quality system violations.