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U.S. Department of Health and Human Services

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Enforcement Actions

Superex Canada Ltd 5/10/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

 

May 10, 2013
 WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
 
Cees Spoorenberg
Vice President/General Manager
Superex Canada Ltd.
601 Gordon Baker Road
Toronto, Ontario, Canada M2H 3B8
 
Dear Mr. Spoorenberg:
 
During an inspection of your firm located in Toronto, Canada, on January 21, 2013, through January 22, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures first aid and emergency response kits. 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 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.
 
We received an undated response from Mohamed Ayube, Operations Manager, on February 12, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which 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 procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).  For example, your firm does not have a written procedure for implementing corrective and preventive actions (CAPAs), including procedures for verification or validation of CAPAs to ensure that such actions are effective and do not adversely affect the finished device.  While your firm’s Complaint Handling Procedure for Medical Devices, Version 1.2, Revision 2, dated May 29, 2012, mentions corrective actions, it does not include any specifics for that process.

We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will add CAPAs to its Complaint Handing Procedure for Medical Devices. However, your firm did not provide any documentation that includes a description and evidence of implementation of the correction and the corrective action. Your firm also did not indicate that a retrospective review of all previous complaints and CAPAs will be conducted.   

2.    Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm’s Warehouse Stock and Shipping Procedure, Version 1.1, dated May 29, 2012, requires that all expired, returned, and recalled items are stored in a well-defined quarantine area to prevent these items from being inadvertently shipped. During a tour of the warehouse area, it was observed by the investigator that the area described as the location for quarantined items was not well-defined as the area lacked any physical separation or signage to indicate that it was a quarantine area.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that a quarantine area has been established with signage. However, your firm did not provide any documentation that includes evidence of implementation of a systemic corrective action. 
 
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, your firm does not have written purchasing control procedures for qualifying and auditing suppliers.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any documentation that includes a description and evidence of implementation of a correction or a corrective action.    
 
4.    Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, your firm’s employees in the receiving area do not follow any written procedures and do not document their evaluation of incoming medical devices or kit components.
 
Your firm’s response did not address this deficiency.
 
5.    Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, according to your firm’s management, employees in the kit assembly area check their own finished work. No other person at your firm is responsible for, or performs, final review and approval. There is no established procedure describing who is responsible for authorizing release of finished devices. There is no documented release for any of your firm’s finished medical device kits.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will establish a procedure to include sign off for release by a supervisor or other designated individual before shipments leave your firm. However, your firm did not provide any documentation that includes a description and evidence of implementation of the correction and the corrective action.
 
6.    Failure to establish and maintain procedures to control environmental conditions that could reasonably be expected to have an adverse effect on product quality and failure to periodically inspect environmental control systems to verify that the system is adequate and functioning properly, as required by 21 CFR 820.70(c). For example, your firm’s Warehouse Stock and Shipping Procedure, Version 1.1, dated May 29, 2012, states that all items must be stored (b)(4); that items are handled and stored to prevent damage and deterioration; and that the storage area is kept clean and dry. During a tour of the warehouse area, it was observed by the investigator that employees had stored open cardboard boxes of kit components directly (b)(4).
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that items have been stored (b)(4). Your firm also indicated that (b)(4). However, your firm did not provide any documentation that includes evidence of implementation of the correction and the corrective action.
 
7.    Failure to establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 CFR 820.150(a). For example, your firm’s Warehouse Stock and Shipping Procedure, Version 1.1, dated May 29, 2012, states that all items with dates or shelf life are stored in (b)(4) process. However, management stated that your firm currently does not have an inventory system capable of tracking dates or shelf life of products. 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any documentation that includes a description and evidence of implementation of a correction or corrective action.
 
8.    Failure to maintain device history records (DHRs), as required by 21 CFR 820.184. For example, your firm does not maintain any DHRs for finished lots of medical devices. Lot numbers for each utilized component are not documented. The only lot documentation maintained by your firm is the Purchase Order, which contains a list of components to be included in each kit. There is no documentation or verification to show what components are used in each finished kit.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will establish a procedure to ensure traceability of existing lot numbers by adding them to current work orders. However, your firm did not provide any documentation that includes a description and evidence of implementation of the correction and corrective action.
 
9.    Failure to establish and maintain an organizational structure to ensure that devices are designed and produced in accordance with the requirements of management controls, as required by 21 CFR 820.20(b). For example, firm management has not established a comprehensive quality system, quality plan, or quality policy; has not performed or documented any internal audits; has not documented the appointment of a quality system management representative; and has not documented discussion of quality issues or conducted quality management review meetings.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will establish a procedure to include the missing requirements.  However, your firm did not provide any documentation that includes a description and evidence of implementation of the correction and corrective action.
 
Our inspection also revealed that your firm’s 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.  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, your firm’s Procedure for Mandatory Problem Report, Version 1.1, dated May 29, 2012, does not include any reference for submission of MDRs to FDA. The procedure references reporting events to Health Canada; however, reporting to FDA is not mentioned in this or any other procedure.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will add FDA contact information to its reporting procedure. However, your firm did not provide any documentation that includes a description and evidence of implementation of the correction and corrective action that addresses MDR submission.
 
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 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.  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 #393555 when replying. If you have any questions about the contents of this letter, please contact Carl Fischer at 301-796-5770 or 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 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. 
 
                                                                       
Sincerely yours,
/S/                                                           
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health