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FDA Issued Serious Warning to C. R. Bard, Inc. Due to Multiple Violations

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[By Staff Writer Jay Belle Isle]

In a letter dated July 13, the FDA issued serious warning to C. R. Bard Inc. due to multiple violations. The company has been given fifteen business days to respond to the letter or else it may face “seizure, injunction and civil money penalties.” The warning is based on inspections of Bard’s Queensbury, NY and Tempe, AZ manufacturing facilities and is focused on Bard’s Recovery Cone Removal System, Models RC-15 and FBRC.

The FDA has several concerns with these devices, including that they are:

…adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).

… misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

market[ed] … without marketing clearance or approval. Percutaneous retrieval systems, such as the Recovery Cone Removal System, Model RC-15, are regulated as manual surgical instruments intended for specialized use within a specific medical specialty, and thus require marketing authorization in order to be legally marketed in the United States.

Further, the inspection revealed issues with Quality Control of Bard’s IVC filters:

Specifically, IVC filter cleaning, to include removal of chemical processing contaminants, has not been validated for IVC Filters to include Simon Nitinol Filters, Eclipse Filters and Denali Filters. For example, production of Denali Filters requires the use of several processing agents, including, but not limited to the following: nitric acid, methanol, sulfamic acid solution, thermo quench salt, glycolic acid, citric acid, and/or hydrofluric acid. The cleaning processes for IVC filters are not validated or otherwise verified to demonstrate that the above substances are reduced to acceptable levels during routine processing under worst case conditions. Therefore, your manufacturing process was not validated with a high degree of assurance and approved according to established procedures, nor were the process results fully verified by subsequent inspection and test, as 21 CFR 820.75(a) requires.  

As if that wasn’t enough, Bard’s system for reporting and investigating product complaints was found to by woefully inadequate.

The company also incorrectly filed or failed to file adverse event reports. One of these reportable instances involved a death potentially due to a Bard device malfunction. Misreporting of 10 cases as Medical Device Reports (MDR) instead of serious injury events was also noted.

The FDA found Bard’s previous answers to the results of the inspections to be insufficient. The company has until August 3 to report satisfactory resolution of the issues or plans to do so.