KayPENTAX, A Division of PENTAX Medical Company 3/29/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4900
MAR 29, 2013
VIA UNITED PARCEL SERVICE
KayPENTAX, A Division of PENTAX Medical Company
3 Paragon Drive
Montvale, New Jersey 07645-1725
Dear Mr. Woods:
During an inspection of your firm located in Montvale, New Jersey, on November 27, 2012 through December 18, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II medical devices such as biomedical instrumentation devices which are used in the medical assessment or behavioral therapy of patients with speech, voice and swallowing disorders. 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.
The inspection revealed that the 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 (cGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from Mr. Michael A. Pereira, Vice President, dated January 14, 2013, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm on December 18, 2012. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Your firm has failed to establish and maintain procedures for implementing corrective and preventive action, pursuant to 21 CFR 820.100(a).
For example, the Corrective and Preventive Action Procedure, Document No. OP-19, did not include the requirements of implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems and submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review. Additionally, CAPA Action Records do not include verification or validation of corrective actions.
We reviewed your firm's response, dated January 14, 2013, and conclude the adequacy of your response cannot be determined at this time. Your response states that you will be writing a new CAPA System Program that will be implemented and that your current system will become obsolete. Please provide supporting documentation demonstrating this proposed change as the data becomes available for our review.
2. Your firm has failed to maintain adequate complaint files, pursuant to 21 CFR 820.198(a).
For example, the Customer Complaint Handling Procedure, Document No. OP-020, requires that a root cause investigation be documented. However, the following are examples of complaints which had not been thoroughly investigated for root cause: #19205, #19209, and #23056.
We reviewed your firm's response, dated January 14, 2013, and conclude the adequacy of your response cannot be determined at this time. Your response states that you will be utilizing a Complaint System Program from PENTAX Medical Global Complaint Handling System and that your current system will become obsolete. Please provide supporting documentation demonstrating this proposed change as the data becomes available for our review.
3. Your firm has no documented agreements with suppliers and contractors to notify you of changes in products or services, pursuant to 21 CFR 820.50(b).
For example, you did not provide any documented agreements with your medical device subcontractors and vendors requiring that any changes in products or services, which may affect the quality of the device, are communicated. Additionally, the Purchasing Procedure, Document No. OP-009 and Policy for Vendor Assessment, PUR-0200-3, do not include the requirements of maintaining a documented agreement. Examples of active vendors without a written agreement include Advanced Circuits Inc. (supplies unpopulated PCB's); TUV Rheinland of N. America (services the devices for electromagnetic compatability testing); and Youngtron, Inc. (supplies the assembled PCB's).
We reviewed your firm's response, dated January 14, 2013, and conclude the adequacy of your response cannot be determined at this time. Your response states that the medical purchasing process is currently being reviewed and that a quality supplier agreement is being drafted. Please provide supporting documentation as the data becomes available for our review.
4. Your firm failed to establish procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, pursuant to 21 CFR 820.250(a).
For example, your In-Process and Final Inspection Procedure, Document No. OP-015, states that the final inspection of the finished device is done in accordance with the specification checklist or test procedure. However, for instrument serial numbers (b)(4), established limits for voltage and amplitude measurements lacks assurance that limits are established according to a valid statistical technique to verify the acceptability of process capability and product characteristics.
We reviewed your firm's response, dated January 14, 2013, and conclude the adequacy of your response cannot be determined at this time. Your response states that statistical applications will begin in the purchasing area for incoming components and you will begin migration into other areas of the Quality System once tested for effectiveness. Please provide supporting documentation as the data becomes available for our review.
Our inspection also revealed that the Phonatory Aerodynamic system (PAS), Model 6600; Nasometer II, Model 6450, Sona-Speech II, Model 3650; and Visi-Pitch IV, Model 3950B are Class II devices which are adulterated under Section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under Section 520(g) of the Act, 21 U.S.C. § 360j(g).
The devices are also misbranded under Section 502(o) of the Act, 21 U.S.C.
§352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by Section 510(k) of the Act, 21 U.S.C.
§360(k). For a device requiring premarket approval, the notification required by Section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The type of information that your
firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/d. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
We reviewed your firm's response, dated January 14, 2013, and conclude that the response is not adequate. You have not submitted any data to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation for review, such as a pre submission or 513(g), in order for your medical devices to be reviewed for the need of a 510(k).
It is your responsibility to evaluate all of your devices to determine if a 510(k) is necessary. Your firm continues to distribute medical devices which have not been reviewed for safety and efficacy
A follow up inspection will be required to assure that correction and/or corrective actions are adequate. 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/or 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 awarding 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.
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.
Your firm's response to this letter should be sent to: U.S. Food and Drug Administration, 10 Waterview Blvd, 3rd Floor, Parsippany, New Jersey 07054. If you have any questions about the contents of this letter, please contact Stephanie Durso, Compliance Officer, at 1-973-331-4911 (phone) or 1-973-331-4969 (fax).
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 determinethe causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
New Jersey District