Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District Office|
One Montvale Avenue, 4th floor
Stoneham, MA 02180
VIA UPS OVERNIGHT
August 12, 2013
Mr. Ronald T. Diamond
President and CEO
One Cummings Point Road
Stamford, Connecticut 06904
Dear Mr. Diamond:
During an inspection of your firm located in Stamford, Connecticut on May 21 through May 31, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures heating pads.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.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting, as required by 21 CFR 820.198(a)(3). Your complaint procedure does not discuss how heating pad complaints of injury are evaluated by your Claims Department. For example:
a. On April 29, 2013, your firm received Complaint #13-22941, that referenced a third degree burn. There was no attempt to contact the complainant to obtain additional information regarding the injury.
b. On September 20, 2012, your firm received Complaint #12-22120, that referenced a third degree burn which required going to the burn center. There was no attempt to contact the complainant to obtain additional information regarding the injury.
c. On December 4, 2012, your firm received Complaint #12-22366, that referenced a burn to the lower abdomen which required medical attention. There was no attempt to contact the complainant to obtain additional information regarding the injury.
2. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm does not have a design control procedure in place to assure that your marketed devices meet specified design requirements. During the inspection you were not able to provide detailed design information for your currently marketed heating pads, including Model HP01RB, which was the subject of at least (b)(4) burn complaints in the past 2 years.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm does not have a written CAPA procedure to assure that complaints are analyzed to identify existing and potential causes of nonconforming product or other quality problems. During the inspection we reviewed numerous complaints regarding burns caused by your heating pads, however, your firm did not have any formal process to review these complaints to identify any existing or potential causes of nonconforming product or other quality problems.
Our inspection also revealed that your firm’s heating pad 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 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
- Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggested that 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, the information included for Complaint 13-22941, dated April 29, 2013, describes a serious injury considered reportable to the Agency. The event describes a patient receiving a third degree burn following use of the Conair Heating Pad Model #HP01RB.
- Failure to submit a report to FDA no later than 30 calendar days after the day your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device it markets has malfunctioned and this device or a similar device that it markets would likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example, the information included for Complaints 12-21366 and 12-21253, reasonably suggest that the device that is the subject of the complaints malfunctioned and as a result of the malfunction, the device sparked and caught fire, and flames were observed within the device.
- Failure to develop, maintain and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, written MDR procedures have not been developed by your firm.
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations 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 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.
A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.
Your firm’s response should be sent to: New England District Office. Refer to the Unique Identification Number (CMS case 406221) when replying. If you have any questions about the contents of this letter, please contact: Karen Archdeacon at 781-587-7491.
We acknowledge a response dated August 5, 2013 from John L. Feeney, Associate Counsel, which responded to our investigator's observations noted on the Form (FDA 483) List oflnspectional Observations issued to your firm on May 31, 2013. You should note that we did not perform an in-depth review of this response since it was not received with 15 days of the FDA-483 issuance. You may reference this documentation in your response to this Warning Letter.
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.
Joseph Matrisiciano, Jr.
Acting District Director
New England District