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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Davol, Inc. 4/24/07

Department of Health and Human Service's Eagle LogoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
 New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781)596-7700
FAX: (781)596-7896

WARNING LETTER

NWE-16-07W

VIA CERTIFIED MAIL

April 24, 2007

Mr. Daniel W. LaFever
President
Davol, Inc., Sub C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston, RI 02920

Dear Mr. LaFever:

We are writing to you because on January 23 through March 13, 2007, the Food and Drug Administration (FDA) conducted an inspection of your Davol Inc., facility located at 100 Sockanossett Road in Cranston, Rhode Island and observed serious regulatory problems involving your Composix Kugel Hernia Patches and Salute Fixation devices.

Under a United States law, the Federal Food, Drug and Cosmetic Act, (the Act) these products are considered to be medical devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans. Moreover, your activities, including the design and manufacture of these devices, make you a manufacturer under the law.

The inspection found that these devices are adulterated under section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation at Title 21 Code of Federal Regulations, (21 CFR), Part 820. Significant deviations include, but are not limited to, the following:

1. Failure to establish and maintain an adequate corrective and preventive action procedure which ensures identification of actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).

For example, your firm initiated a class I recall in December, 2005 of all of your Extra Large Composix Kugel Hernia Patches due to breaks of the ring weld. In March, 2006, you expanded this class 1 recall to include other sizes of your Composix Kugel Hernia Patches due to three additional complaints of ring weld breaks. This second, expanded recall only included product manufactured prior to January 2004. Yet on March 31, 2006 and May 12, 2006, you received two additional complaints of ring breaks on large Composix Kugel Hernia Patches that were manufactured after January 2004. Your class 1 recall of the Composix Kugel Hernia Patches, manufactured after January 2004, was not initiated until January 10, 2007.

Your recall procedure, QA#-14.2, states, "time is of the essence where product problems present a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death (eg., class I type recall). . . "

2. Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained as required by 21 CFR 820.20.

During the FDA inspection, we observed significant violations as they relate to a number of quality system regulations, including your corrective and preventive action (CAPA) controls as demonstrated by the above example. Similar deficiencies were previously brought to your attention in a FDA 483 dated February 7, 2006, after an FDA inspection on January 25, 2006. Recurring, serious deficiencies in this area point to a failure of your quality management system.

We acknowledge your response to the FDA-483 dated March 27, 2007 and your promised corrective actions. We believe that the changes you described will address the specific issues that were identified in the FDA-483. In your response to this Warning Letter, please address how your management will be addressing any additional changes in your global quality system that will prevent similar violations from recurring. We need to be assured that an effective quality system will be implemented immediately.

3. Failure to document the implementation of corrective and preventive actions, as required by 21 CFR 820.100(b). For example, CAPA #Q6023, (opened on April 28, 2006 and closed on June 13, 2006), was initiated as a result of your class 1 recall of the Composix Kugel Hernia Patch due to ring weld breaks. This CAPA included the following specific action to be taken, "... establish complaint threshold limits for recoil ring break complaints & continue to monitor trends." During the inspection, no documentation could be provided to our Investigator that demonstrated these limits had been established prior to closing of the CAPA.

We acknowledge your response to the FDA-483 that indicated the document was missing. You also provided a document dated March 12, 2007, that indicates a threshold limit of [redacted] has now been established. Your response goes on to describe that this threshold limit of [redacted] had always been in effect as evidenced by an undated document which you provide in appendix 3. We note that if this threshold limit had been in effect in 2006, i.e., upon receipt of at least six complaints from March 31, 2006 through August 29, 2006, your firm would have been required to initiate a corrective action much sooner.

4. Failure to validate your device's design to ensure that the device conforms to defined user needs and intended uses, as required by 21 CFR 820.30(g). For example, there was no documentation to demonstrate that design validation was performed on your Salute Reusable Fixation device. During the inspection, we observed a performance specification for your Salute Reusable Fixation device which states, ". . .the reusable assembly shall be capable of producing [redacted] Q Rings without compromising performance". There was no documentation available to demonstrate that any testing was performed to ensure that the Salute Fixation device met this specification.

Your response to the FDA-483 states that validation was performed by [redacted] in 2002; however these files were archived and could not be located during the inspection. Your response does not address the failure of your design control system to ensure that the Salute Reusable Fixation device was evaluated and that it conformed to defined user needs and intended uses.

We acknowledge your ongoing field action of your Salute Reusable Fixation device, FDA recall #Z-0374/0375-2007, due to numerous complaints and MDR's of the device failing to function as intended.

5. Failure of your firm to establish procedures to completely address the identification, documentation, evaluation, segregation, disposition and investigation of non-conforming product as required by 21 CFR 820.90(a).

For example, procedures are lacking to ensure consistency in the handling and timing of activities from complaint receipt, complaint investigation, product assessment team meetings and remedial action plans to the determination of actual recall actions. In examining Davol's numerous recalls of the Composix Kugel Hernia Patches and the Salute Reusable Fixation device, we observed quality system failures that resulted in delays in the ultimate disposition of non-conforming product.

This letter is not intended to be,an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your establishment's quality system. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.

You should know that these serious violations of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties.

Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket submissions for Class III devices to which the Quality System/Current Good Manufacturing Practice deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.

We acknowledge the receipt of your letter dated March 27, 2007 which responded to the FDA 483 that was issued to your facility on March 13, 2007. We have also received your two updates to this response dated April 2 and 13, 2007. Your responses describe specific corrective actions that promise to bring your facility into compliance, i.e., revised SOP's and additional training activities.

We request a meeting with your firm to discuss these corrective actions. The violations included in this Warning Letter and discussed above concern significant deficiencies across all of your quality systems, including corrective and preventive actions (CAPA's) that warrant your immediate attention to ensure that an effective quality system is in place. Please come prepared to discuss your ongoing recalls and your efforts to prevent the recurrence of these violations. You may contact Ms. Archdeacon, contact information below, to schedule this meeting.

Please let this office know in writing what steps you have taken to correct the noted problems within fifteen (15) working days from the date you received this letter. We also ask that you explain how you plan to prevent these problems from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to Karen Archdeacon, Compliance Officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. Her telephone number is (781) 596-7707; FAX No. 781-596-7899.

Sincerely yours,

/S/

Gail T. Costello
District Director
New England District

Attachment: FDA-483 dated March 13, 2007

Cc: Mr. John H. Weiland
President and COO
C.R. Bard Inc.
730 Central Ave.
Murray Hill, NJ 07974