A recent Warning Letter sent by the US Food and Drug Administration (FDA) to a medical device manufacturer contains good advice to any firm facing an enforcement action from federal regulators: Ignoring the issue will not make it go away.
FDA's letter was sent to California-based contact lens manufacturer Visionary Contact Lens. The company, which makes rigid gas-permeable contact lenses, was inspected by FDA officials in January and February 2015.
During FDA's inspection of the firm, officials said they found deficiencies within the company's quality system, which is regulated by FDA under 21 CFR 820. Alleged problems included the company failing to validate production software, failure to ensure manufacturing equipment met specified requirements, deficiencies within the company's Corrective and Preventive Action (CAPA) procedures and more.
Those deficiencies aren't necessarily unusual. According to data compiled last year by FDA, the agency issues hundreds of deficiency notices—known more commonly as Form FDA 483s—for Quality System Regulation (QSR) deficiencies.
Most Common Medical Device Regulatory Deficiencies as Cited by FDA
|Regulatory Citation||Short Description||Long Description||Frequency|
|21 CFR 820.100(a)||Lack of or inadequate procedures||Procedures for corrective and preventive action have not been [adequately] established.||360|
|21 CFR 820.198(a)||Lack of or inadequate complaint procedures||Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.||251|
|21 CFR 820.50||Purchasing controls, Lack of or inadequate procedures||Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established.||129|
|21 CFR 820.75(a)||Lack of or inadequate process validation||A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures.||122|
|21 CFR 803.17||Lack of Written MDR Procedures||Written MDR procedures have not been [developed] [maintained] [implemented].||117|
A Lack of Response is not a Strategy
What was unusual was Visionary's response to FDA's inspection findings.
At the conclusion of its inspection, FDA sent Visionary a Form FDA 483 outlining several problems in need of attention and remediation. Under normal circumstances, most companies immediately work to respond to the letter, explain steps they have taken to correct the problem and discuss how they will ensure the problems will not happen again in the future. In some cases, companies will also work to clarify information and even contest certain findings if they believe they were unwarranted or improper.
FDA's Warning Letter alleges Visionary instead took a third approach: ignoring its Form FDA 483 altogether.
"We did not receive a response from your firm to our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm on February 26, 2015," FDA wrote in its letter.
By ignoring FDA's initial Form FDA 483, the company was automatically sent the Warning Letter, which largely summarized the content of the 483. Many Warning Letters will outline both the Form 483 and the company's response to the alleged deficiencies. If the company's response to a problem was adequate, FDA will say so in its letter.
Visionary now has just 15 days to respond to FDA's Warning Letter. Failure to respond to the letter could result in the company's products being seized and the company being shut down and subject to civil penalties.
FDA's Warning Letter