A March inspection of the Andover, Massachusetts manufacturing facilities of medical device maker Smith & Nephew has resulted in a Food and Drug Administration (FDA) warning letter to the company based on problems uncovered the inspection.
The inspection took place between March 4 and March 25. Inspectors discovered problems with arthroscopy (joint replacement) and gynecology devices, including the TRUCLEAR ULTRA Reciprocating Morcellators 4.0, a surgical device.
Under section 201(h) of the Federal Food, Drug, and Cosmetic Act, medical devices are products “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.” Joseph Matrisciano, the acting district director for the FDA’s New England office, explains that a number of Smith & Nephew devices are “adulterated” under the meaning of section 501(h) of the law because “methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements.”
Smith & Nephew “failed to establish and maintain procedures for verifying or validating corrective and preventive actions (CAPA) to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).” For example, Matrisciano wrote, eight corrective action reports were reviewed during the inspection and they did not contain sufficient information to ensure corrective actions were completed and verified as effective.
Among the problems Smith & Nephew must address are an incorrect translation of the term, “non-absorbable suture” in the IFU for TwinFix Ultra Preloaded Suture Anchors; an increased complaint rate for Beaver Blade device breakage in the field; and a large number of complaint investigations that had been open for greater than 90 days. At the time of the inspection, the FDA said, there was no documentation that all open action items had been completed.
The FDA deemed Smith & Nephew’s response to the inspection inadequate because the company did not provide complete documentation of corrections. A company receiving a warning letter has fifteen business days from receipt of the letter to respond. The company must provide specific steps taken to correct violations and plans to prevent these violations, or similar violations, from occurring again. The response must include documentation of corrective actions, must address systemic problems, and must include a timetable for any actions that will “occur over time.” If necessary corrective actions cannot be completed within fifteen business days, Smith & Nephew must give reasons for the delay and tell the FDA when the activities will be completed.
Failure to promptly correct these violations could result in regulatory action including, but not limited to, seizure, injunction, and monetary penalties. In addition, premarket approval applications for Class III Smith & Nephew devices to which the regulation violations are “reasonably related” will not be approved until the violations have been corrected. Certificates to Foreign Governments, needed to market devices overseas, will not be granted until violations have been corrected.