On April 30, 2015, the Food and Drug Administration (FDA) sent a warning letter to medical device maker Smith & Nephew based on problems observed during an inspection of the company’s manufacturing facilities, March 4 to March 26, 2015.
According to the letter, inspectors discovered problems with arthroscopy (joint replacement) and gynecology devices, including the TRUCLEAR ULTRA Reciprocating Morcellators 4.0.
Under section 201(h) of the Federal Food, Drug, and Cosmetic Act, 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.” The letter goes on to explain that these 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.”
The FDA said Smith & Nephew had 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, the FDA said, during the inspection eight corrective action reports were reviewed and did not contain sufficient information to ensure corrective actions were completed and verified as effective.
Among the problems the company must address is 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 said Smith & Nephew’s response was not adequate because the company did not provide complete documentation of corrections. Smith & Nephew has fifteen business days from receipt of the warning letter to respond and give the FDA the specific steps the firm has taken to correct the noted violations, as well as an explanation of the firm plans to prevent these violations, or similar violations, from occurring again. The company must include documentation of the corrections and/or corrective actions, which 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 the reason 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.