Inspections, Compliance, Enforcement, and Criminal Investigations
Safecross First Aid Ltd 3/26/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993-0002
March 26, 2013
VIA UNITED PARCEL SERVICE
Safecross First Aid Ltd
21 Kodiak Crescent
Canada M3J 3E5
Dear Mr. Perry:
During an inspection of your firm located in Toronto, Ontario, Canada, on January 23, 2013, through January 24, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures first aid kits and components for first aid 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.
Our inspection revealed that your firm’s first aid kits and components for first aid kits 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.
Your firm’s response dated February 15, 2013, to the Form FDA 483 (FDA 483), was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
For example, the Safecross Standard Operating Procedure No. 80.04, Mandatory Problem Reporting, effective date January 20, 2009, only covers reporting of “major problem incidences” according to Health Canada Guidelines. The procedure does not mention any requirement for Medical Device Reporting or the timeliness for submitting medical device reports to FDA. The Safecross Quality Manager also indicated that your firm does not have any written MDR procedure.
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.
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. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act, 21 U.S.C. § 351(h), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
1. Failure to maintain complaint files and 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, the Safecross Quality Manager indicated to the investigator that your firm did not have any complaints. During the inspection, it was determined that your firm had reports of (b)(4) and (b)(4); however, these reports were not classified as complaints. According to Safecross Complaints Handling SOP 80.02, effective date January 20, 2009, your firm is to list all complaints in the “Products Complaints Binder.” However, the binder did not list any complaints.
2. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c).
For example, the Safecross Quality Management System Manual states that Management Responsibility includes, “Conducting periodic quality management reviews.” The Manual also requires management reviews to be documented. Despite the fact that the Quality Manager indicated that management reviews are conducted periodically, your firm could not produce any documentation that demonstrated that management reviews were being conducted.
3. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
For example, your firm’s Quality Management System Manual states that internal audit results are required to be recorded. Safecross’ Internal Quality Audit SOP 85.02, dated January 20, 2009, also states that the Quality Manager prepares final audit reports and meets with the production team to discuss major non‑compliances observed during the audit. The Quality Manager indicated that your firm had conducted quality audits; however, Safecross had not documented the dates and results of these quality audits.
Your firm’s response to this letter 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 the Unique Identification Number CMS Case #393666 when replying. If you have any questions about the contents of this letter, please contact: Carl Fischer, Ph.D., at 301-795-5770 or by fax at 301-847-8137.
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.
Steven D. Silverman
Office of Compliance
Center for Devices and