Inspection Triggers FDA Warning Letter to Smith & Nephew

A March inspection of the manufacturing facilities of medical device maker Smith & Nephew have resulted in a Food and Drug Administration (FDA) warning letter to the company based on problems observed during an inspection.

FDA inspectors discovered problems with arthroscopy (joint replacement) and gynecology devices, including the TRUCLEAR ULTRA Reciprocating Morcellators 4.0.  

Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines devices as 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.” In the letter, Joseph Matrisciano, the acting district director for the FDA’s New England regional 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.

The company must address problems including 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 inadequate because the company did not provide complete documentation of corrections. Smith & Nephew has fifteen business days from receipt of the letter to respond and provide specific steps the firm has taken to correct the noted violations, as well as an explanation plans to prevent these violations, or similar violations, from occurring again. The company must include documentation of the corrections and/or corrective actions, must address systemic problems, and must include a timetable for actions that will “occur over time.”  If corrective actions cannot be completed within fifteen business days, Smith & Nephew must give reasons and state the time within which these activities will be completed.

The FDA wrote that failure to promptly correct these violations may result in regulatory action including, but not limited to, seizure, injunction, and civil money penalties. In addition, Smith & Nephew’s premarket approval applications for Class III devices to which the regulation violations are “reasonably related” will not be approved until the violations have been corrected.  Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

 

 

 

 

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