Inspections, Compliance, Enforcement, and Criminal Investigations
Chattem, Inc. 06-Jun-08
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone: (615) 366-7801
June 6, 2008
WARNING LETTER NO. 2008-NOL-13
DELIVERY SIGNATURE REQUESTED
Robert E. Bosworth, President
1715 38th Street
Chattanooga, Tennessee 37409-1248
Dear Mr. Bosworth:
During an inspection of your firm, located at 1715 West 38th Street, Chattanooga, Tennessee on February 5-8, 2008, investigators from the United States Food and Drug Administration (FDA) determined your firm manufactures Icy Hot Heat Therapy Patches. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code (USC) 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 are intended to affect the structure or function of the body.
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). We received two written responses from you dated February 14, 2008 and February 20, 2008, concerning our investigators' observations noted on the Form FDA 483, List of Inspectional Observations, issued to you. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. You failed to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your Corrective and Preventive Action Standard Operating Procedure (CAPA SOP), [redacted] does not address all of the requirements under 21 CFR 820.100(a)(1)-(7), including, but not limited to, analysis of all sources of quality data (e.g., returned product, service reports), appropriate statistical methodology, and verifying or validating the corrective and preventive action to ensure that such action is effective and does not affect the finished device. Further, your firm received approximately 200 complaints concerning the Icy Hot Heat Therapy Patches, including burns, skin removal, and skin irritation, which are defined under your SOP as major complaints requiring a CAPA. Your firm failed to initiate a CAPA to address these complaints.
Your response appears to adequately address our concerns about CAPA procedures and reportable events (A-01-04 and L-314-080b). However, you have not provided documentation showing personnel have been adequately trained on the revised complaint and CAPA procedures to include thorough investigations.
In addition, our inspection revealed your Icy Hot Heat Therapy devices are misbranded under Section 502(t)(2) of the Act, 21 USC 352(t)(2), because your firm failed or refused to furnish material or information with respect to the device, which is required by or under Section 519 of the Act, 21 USC 360i, and 21 CFR 803, Medical Device Report (MDR) regulation, and 21 CFR 806, Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:
1. You failed to submit a MDR within 30 days of receiving or otherwise becoming aware of information which reasonably suggests a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example, your firm failed to submit fifteen (15) MDRs to FDA within 30 days of receiving or otherwise becoming aware of information which reasonably suggests Icy Hot Therapy devices may have caused or contributed to a death or serious injury.
You acknowledge the company did not report the events within the 30-day requirement. Your response indicates the MDRs were reported to FDA. Your firm did not provide documentation showing personnel have been adequately trained on the MDR procedures and the procedures have been successfully implemented.
2. You failed to submit a written report to FDA of a correction or removal of a device initiation
by your firm to reduce a risk to health posed by the device, as required by 21 CFR 806.10(a)(1). For example, your firm failed to notify FDA of a labeling change which was implemented to reduce the risk to health from bums, skin removal, and skin irritation associated with your Icy Hot Heat Therapy patches. The labeling change was initiated as a response to more than 168 complaints from consumers using your product.
Your response is inadequate. FDA acknowledges your firm submitted information regarding the labeling change in accordance with 21 CFR 806, and conducted a Class II Recall on February 7, 2008. However, your firm has failed to provide FDA with the revised Recall Standard Operating Procedure which addresses all requirements of 21 CFR 806.10(a)(1). Your response states the revised procedure will be approved by February 22, 2008, but to date it has not been received in this office. Your firm did not provide documentation showing personnel have been adequately trained on the Recall procedures. We acknowledge receipt of your SOP L-314-80b, which covers adverse events and dispositions.
Our inspection revealed your Icy Hot Heat Therapy devices are misbranded under Section 502(f) of the Act, 21 USC 352(f), because the labeling fails to bear adequate directions for use and adequate warnings against use in certain pathological conditions, or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application. For example, the labeling deficiencies include, but are not limited to, the following:
1. The labeling does not explain the differences between the "WARNINGS" and "DO NOT USE" sections of your labeling.
2. The duration of use of "up to 8 hours" raises significant clinical concerns as this duration exceeds the established time at which a 2nd degree burn has been shown to occur on human skin at the target temperature of the patch. The labeling needs to provide adequate directions for use with respect to the duration the device is to be applied to the patient's skin.
3. The labeling does not clearly differentiate between the populations who should not use the patch from those who must not use the patch.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Premarket approval applications for Class III devices, to which the Quality System regulation deviations are reasonably related, will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.
Your response should be sent to Kari L. Batey, Compliance Officer, at 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have any questions about the content of this letter, please contact Ms. Batey at (615) 366-7808.
This letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Form FDA 483, Inspectional Observations, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the cause of the violations, and take prompt action to correct the violations and bring your products into compliance.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483