Smith & Nephew Cited for Procedures, CAPAs

Smith & Nephew drew a Form 483 for multiple issues at its Memphis, Tennessee facility, including a faulty procedure for the control of nonconforming product and inadequate corrective and preventive action procedures.

The firm lacked an adequate procedure for the control of nonconforming product or to ensure that assessments of nonconforming products were properly documented. For example, the procedure required an investigation of discrepancies, including missing laser engraved batch numbers, but provided no method to ensure investigations were performed or recorded.

The FDA investigators observed that a corrective and preventive action was also not adequately established. The firm failed to conduct or record activities in a timely and effective manner. For example, a request to initiate a CAPA took over a year to be evaluated by the review board and was not signed as approved until three months after its evaluation. No investigation was performed into the cause of the problem or any subsequent impact on product.

In addition, the firm did not establish a sufficient complaint handling unit. Specifically, its orthopedic instrument repair processing specification procedure required information to be shared when a device could not be repaired or a deficiency became evident. However, multiple device repair orders were not shared.