Inspections, Compliance, Enforcement, and Criminal Investigations
National Therapy Products, Inc. 10/11/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
OCT 11 2011
VIA UNITED PARCEL SERVICE
National Therapy Products, Inc.
191 Rowntree Dairy Rd.
Woodbridge, Ontario, Canada L4L 8B8
Dear Mr. Hooey:
During an inspection of your firm located in Woodbridge, Ontario, Canada, on June 20, 2011, through June 21, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Wavelength Ultrasound Gel. 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 are intended to affect the structure or function of the body.
Our inspection revealed that the Wavelength Ultrasound Gel 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. These violations include, but are not limited to the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, when requested, you stated that there have never been any serious injuries or malfunctions and did not produce a procedure to govern the evaluation and handling of reportable adverse events.
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 awarding of contracts.
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. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501 (h) of the Act (21 U.S.C. § 351 (h)), which are deficiencies within your firm's quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformances include, but are not limited to, the following:
Failure to establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements, and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
For example, quality procedures have not been established and quality audits have not been conducted since 2007. When information was requested regarding quality audits, the firm's representative noted that the procedure is under construction and internal audits have not been conducted since 2007.
Your firm's response to this letter should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to the Unique Identification Number 225494 when replying. If you have any questions about the contents of this letter, please contact: Charles Cathlin, RAND Branch Chief at 301-796-5548 or 301-847-8138.
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.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health