Inspections, Compliance, Enforcement, and Criminal Investigations
Intelligent Hospital Systems 2/8/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
FEB 08 2012
VIA UNITED PARCEL SERVICE
Dr. Niels Erik Hansen
President and CEO
Intelligent Hospital Systems
96 Nature Park Way
Winnipeg, MB R3POX8, Canada
Dear Dr. Hansen:
During an inspection of your firm located in Winnipeg, Canada, on September 19 through September 22, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a pharmaceutical compounding device, named RIVA. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
This inspection revealed that the device is 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, its 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.
Your firm's responses, dated October 31, November 2, and December 5, 2011, to the Form FDA 483 (FDA 483), lnspectional Observations, were not reviewed because they were not received within fifteen business days of issuance. The responses may be evaluated with any other material provided in response to the violations cited in this Warning Letter.
We received a response from Thomas Doherty, Chief Technical Officer, dated October 7, 2011, concerning our investigator's observations noted on the FDA 483, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
• Your firm's Corrective and (b)(4) Procedure, QAP0600, does not define how CAPA investigations will be conducted to determine cause; how all actions needed to prevent recurrence will be identified; and how corrective and preventive actions will be verified or validated to ensure effectiveness and that the actions do not adversely affect finished product.
We reviewed your firm's response dated October 7, 2011, and conclude that it is not adequate. While your firm has provided its updated (b)(4) Procedure QAP0600, the procedure does not include information of how all actions needed to prevent recurrence will be identified. In addition, there is no evidence of implementation or training on the updated procedure.
2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198 (a). For example:
• All complaints to your firm are taken by phone and are received by your firm's call center and technical support employees. The call center and technical support employees use Procedure FDA0903, to process calls and determine whether a call should be forwarded to the your firm's customer satisfaction team as a complaint. However, Procedure FDA0903 does not define the timeframe for conducting the evaluation of the call to determine if it is a complaint, the criteria for what constitutes a complaint, requirements for documenting these activities, and does not reference the firm's (b)(4) Procedure, QAP0500.
The adequacy of your firm's response dated October 7, 2011, cannot be determined at this time. Your firm merged Procedure FDA0903 with Procedure QAP0500, (b)(4) to aid your firm's call center and technical support employees. This revised procedure is used in determining if a call received should be handled as a complaint and sent to the customer satisfaction team for further investigation. Your firm did not provide evidence of implementation of the revised procedure, including training of employees.
3. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example:
• Your firm's production related nonconformances are not processed under the (b)(4) Procedure QCP0100. These nonconformances are documented on an unplanned event log, or for final acceptance, on a non-conformities list within the Final Acceptance Test protocol. Neither these lists, nor (b)(4) QCP0100 define the need for an evaluation of these nonconformances to determine the need for further investigation.
We reviewed your firm's response dated October 7, 2011, and conclude that it is not adequate. While your firm updated (b)(4) Procedure, PRD0101, there is no evidence of a retrospective analysis of the unplanned event logs and final test conformances having been performed, nor is there evidence of the training for this new procedure. Additionally, your firm provided its updated (b)(4) Procedure, QCP0100, which includes how nonconformances will be documented and processed, however, there is no evidence that the procedure has been implemented, nor was a timeframe provided for its implementation or training of your employees on the revised procedure.
4. Failure to establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured; and failure to establish how the requirements for quality will be met, as required by 21 CFR 820.20(d). For example:
• The (b)(4) PRJ0100 does not define all the quality practices, resources, and activities utilized for the design and manufacturing of RIVA. There is no other quality plan or procedure that describes all of the quality system activities and their relationships to the design and manufacturing of the RIVA device.
We reviewed your firm's response dated October 7, 2011, and conclude that it is not adequate. While your firm promised to replace or revise its current (b)(4) PRJ0100 by December 6, 2011, with an updated plan, to not provided evidence that your firm has done so.
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 device 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 #262774 when replying. If you have any questions about the contents of this letter, please contact: Latoya Oliver-Powell, General Hospital Devices Branch, at 1(301) 796-5648 (phone) or 1(301) 847-8137 (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 lnspectional 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