Inspections, Compliance, Enforcement, and Criminal Investigations
CPR Medical Devices, Inc. 12/13/11
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
December 13, 2011
VIA UNITED PARCEL SERVICE
Mr. Romeo Worner
CPR Medical Devices, Inc.
161 Don Park Rd.
L3R 1C2, Canada
During an inspection of your firm located in Ontario, Canada,from July 11, 2011, through July 14, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures hand-held resuscitator devices. 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 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 adequately establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a).
a. Your firm has not ensured the effectiveness of corrective and preventive actions. The investigator reviewed your firm’s Preventive Action Report (PAR) No. P08-001. The PAR was opened to address approved supplier issues regarding updating expired supplier certificates to implement methods of tracking quality certificates for critical vendors. The investigator observed that the PAR contained expired certificate dates for Approved Suppliers, however the PAR was closed. Therefore, the PAR failed to address the issue it was opened to address. Further, the investigator observed that there were no criteria for effectiveness or documentation to support your firm’s conclusion that the preventive action was complete.
b. Product Evaluation Reports (PERs) of returned devices that were repaired and returned to the customer have not been analyzed to investigate the cause of the recurring problem. For example, your firm has not initiated any Corrective Action Report (CAR) since the previous inspection. (b)(4); The investigator reviewed the most current risk analysis documentation that noted the broken stem valves. Your firm had mis-rated the severity of the device failure according to its own procedure. Correct rating would require a quality assurance review and countermeasures to reduce the risk, according to your firm’s “Risk Management” procedure, QSP-71-01, Rev. No. 0. (b)(4);
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, your firm did not follow procedure QSP-82-Q1, "Customer Feedback and Complaints," Rev. No. 0, for initiating a CAR as required in step 1.7. If the customer complaint is not followed with a CAR, the reason is to be documented on the PER and signed off by the Product Manager, per step 1.8. There were no CARs initiated for customer complaints and no reason was documented on any PERs.
3. Failure to review and evaluate all complaints to determine whether an investigation is necessary and to maintain a record that includes the reason for not initiating an investigation, as appropriate, as required by 21 CFR 820.198(b).
For example, the field "Customer Complaint" on the PERs is recorded as "N/A" for complaints numbered FSR148, 149, 150, 152, 153, 154, 155, and 156. There is no detailed information or investigation included on the PERs to support the decision made by CPR Medical Devices that the complaint was not a "reportable incident.” Repairs were made to the device and returned to the customer.
4. Failure to adequately establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c)
For example, your firm’s “Design and Development Control,” QSP-73-01, Rev. No. 0, does not include a requirement to address the needs of the patient. The design inputs for the Oxylator device did not include requirements addressing the patient, such as the consideration of biocompatibility of the material used in the mask and the effect on users’ skin.
5. Failure to adequately establish and maintain procedures for finished device acceptance to ensure that each production run, lot , or batch of finished devices meets the acceptance criteria, as required by 21 CFR 820.80(d).
For example, the Oxylator EMX devices have been released and distributed without meeting the final acceptance criteria for testing established at the time of design transfer to production. The investigator reviewed three records for the last shipment of Oxylator EMX devices shipped to the (b)(4); the records all indicated that they were acceptable per the signature on the test record. The investigator requested further information regarding when the acceptance criteria for the respiratory parameters was changed, as it was different than what was noted in the Design History File listed in the Design Control. The devices were tested and released according to the reference standards listed on the test result printout; however, there was no documentation to support why the parameters were changed, when the changes were made, or that the changes were validated and approved prior to implementation. Your firm’s representative was unable to explain the differences. Since there was no Device Master Record (DMR), the investigator was unable to compare the current specifications with what was approved using a DMR.
6. Failure to adequately establish and maintain procedures for changes to a specification, method, process, or procedure, as required by 21 CFR 820.70(b).
For example, your firm failed to follow its own procedure, QSP-42-04 (b)(4) Rev. 0, step 1, (b)(4) Your firm has made (b)(4); specification changes to the device, Oxylator EMX, since the original design was transferred to production. The changes to the specifications to the device have not been validated or verified and were implemented without approval.
7. Failure to adequately establish and maintain procedures that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 CFR 820.50(b).
For example, your firm’s agreement with suppliers and contractors, dated in 1992, does not require suppliers to notify your firm of changes in the product or service. Specifically, changes to design specifications have been made by the contract manufacturer without notifying CPR Medical Devices. Your firm’s representative noted that there is not an agreement currently in place that stipulates this requirement. Further, the investigator noted that purchase orders do not address the requirement either.
8. Failure to maintain a DMR, as required by 21 CFR 820.181.
For example, your firm does not have a DMR for the Oxylator products. The investigator was unable to verify that the devices are being produced according to current and approved specifications. The investigator observed several handwritten changes to specifications that were not approved, verified, or validated before implementation into production. The investigator also observed that final testing specifications did not match what was approved in the Design History File.
U.S. 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 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including 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 action (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. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response 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 CMS case 244355 when replying. If you have any questions about the contents of this letter, please contact: Charles Cathlin at 301-796-5548 or 301-847-8128.
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, Form 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