| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT 900 U.S. Customhouse |
Department of Health and Human Services
WARNING LETTER
11-PHI-19
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
August 4, 2011
James E. Weedling
President
Patient Transfer Systems, Inc.
407 Elm Avenue
North Wales, Pennsylvania 19454
Dear Mr. Weedling:
During an inspection of your firm located in North Wales, Pennsylvania, on April 28, 2011, through May 9, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Rapid Airway Management Positioners. 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.
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 (CGMP) requirements of the Quality System (QS) 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 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 has not established design control procedures and specific quality requirements for the manufacturing of the Rapid Airway Management Positioner (RAMP). In addition, there is no design history file for this device.
2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm has not established procedures for corrective and preventive actions, to include no procedure for establishing and reviewing quality data involved in the manufacturing of the Rapid Airway Management Positioner (RAMP).
3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example:
(a) Your firm has not established specific quality requirements for the components used in the manufacturing of the Rapid Airway Management Positioner (RAMP).
(b) There are no established quality requirements for the contract manufacturer of the Rapid Airway Management Positioner (RAMP).
4. Failure to maintain device master records, as required by 21 CFR 820.181. For example, your firm has not established a device master record for the Rapid Airway Management Positioner (RAMP).
5. Failure to maintain device history records, as required by 21 CFR 820.184. For example, your firm has no device history records for the Rapid Airway Management Positioner (RAMP) to show that the devices were developed in accordance with an established device master record.
6. Failure to review the suitability and effectiveness of the quality system by management with executive responsibility, as required by 21 CFR 820.20(c). For example, management with executive responsibility has not conducted any management reviews and has not established management control procedures.
Our inspection also revealed that your 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 (MDR) regulation. Significant 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, there is no established procedure for reviewing and evaluating whether an event is MDR reportable. Medwatch Voluntary Report, MW5013990, dated December 11, 2009, and received by your firm on or about February 2, 2010, was not evaluated to determine MDR requirements.
Our inspection also revealed that the Rapid Airway Management Positioner is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device 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) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these 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 response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to Yvette Johnson, Compliance Officer, at the address noted above. Refer to CMS case #193632 when replying. If you have any questions about the content of this letter, please contact Ms. Johnson at 215-717-3077 or yvette.johnson@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations 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 Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/S/
Kirk Sooter
District Director
Philadelphia District
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