Inspections, Compliance, Enforcement, and Criminal Investigations
Kimberly-Clark Corporation 8/8/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 Eighth Street N.E.
Atlanta, GA 30309
August 08, 2012
Mr. Thomas J. Falk
Chief Executive Officer
351 Phelps Drive
Irving, TX 75038
Dear Mr. Falk:
During an inspection of your firm located in Roswell, Georgia, on March 20, 2012, through March 28, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical gowns, patient warming systems, and feeding kits. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are 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, or to affect the structure or any function of the body.
We received responses from you dated March 22, 2012, and April 13, 2012, concerning our investigator’s observation noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address these responses below, in relation to the noted violation. The violation includes, but is not limited to, the following:
Our inspection revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
Failure to submit a written report to the FDA of correction or removal of a device initiated by the manufacturer to reduce a risk to health posed by the device, as required by 21 CFR806.10 (a)(1). For example:
1. Your firm initiated a recall on September 17, 2009, which reported that 21 lots of the MicroCool Breathable Impervious Surgical Gown were abrading in various locations on the surface of the gown during surgery.
2. Your firm initiated a recall on November 13, 2009, which reported that 24 lots of the MicroCool Breathable Impervious Surgical Gown were abrading in various locations on the surface of the gown during surgery.
3. Your firm initiated a recall on December 31, 2010, which reported that the Ultra Fabric Surgical Gowns that were rejected due to loose fibers, and were being used to validate a sterilization packaging validation study, were inadvertently sent to Kimberly Clark Distribution Centers and customers.
4. Your firm initiated a recall on September 16, 2010, which reported that all serial numbers of the Patient Warming System Model 1000 Control Unit were giving an Error 85 Alarm, causing the machine to shut down during use.
5. Your firm initiated a recall on June 22, 2010, which reported that one lot of the MIC Safety PEG Kit (pull type) included a placement guidewire diameter that was too large to pass through the Introducer Needle during the placement procedure of the PEG feeding tube. For two lots, the placement guidewire diameter was smaller than specified.
CDRH determined that the five items listed above should have been reported to the FDA, because the corrections or removals were intended to reduce a risk to health as defined in 21 CFR 806.2(i)(2).
Your firm’s responses to this observation appear to be adequate. Specifically, your firm submitted reports dated March 22, 2012, to FDA for each item described above which contained information required by 21 CFR 806.20. Your firm’s April 13, 2012, response explains recent changes to Device Corrections and Removals Procedure (GL-SOP00077) which dictate that all field corrections will be reported to FDA, and the FDA classification will be compared to the firm’s determination.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify our office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Atlanta District Office, 60 Eighth Street NE, Atlanta, Georgia, 30309. Please refer to the Unique Identification Number (CMS case # 305878) when replying. If you have any questions about the contents of this letter, please contact: Derek Price by phone at (404) 253-2277 or by fax at (404) 253-1205.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance
John R. Gridley
Atlanta District Office
Enclosure: FDA 483, dated 03/28/12
Cc: Thomas Gonzalez, Vice President
1400 Holcomb Bridge Road
Roswell, Ga 30076