Inspections, Compliance, Enforcement, and Criminal Investigations
KooJoo Trading Company 6/24/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993-0002
June 24, 2013
VIA UNITED PARCEL SERVICE
Yong Pil Kim
Chief Executive Officer
KooJoo Trading Company
#116-7, Songma-li, Daegoj myun
Korea, Republic of (South)
During an inspection of your firm located in Gimpo-City, Gyeongki-Do, Republic of South Korea, on April 22, 2013 through April 25, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures lancets and lancing 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 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 a response from you dated May 2, 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 develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example:
a. The sterilization dose range used by your firm’s contract sterilizer for sterilizing the GP Lancets and Safety Lancets does not meet the dose range established by your firm’s sterilization validation. The sterilization dose established by the sterilization validations for both products is (b)(4) to (b)(4); however, your firm’s contract sterilizer uses the dose range of (b)(4) to (b)(4). At least (b)(4) lots of the GP Lancets (b)(4) in 2012 and 2013 received a sterilization dose of (b)(4) to (b)(4). At least (b)(4) lots of the Safety Lancets in 2012 and 2013 received a sterilization dose of (b)(4) to (b)(4). All of these (b)(4) lots were accepted and released for distribution by your firm.
We reviewed your firm’s response and conclude that it is not adequate. Your firm proposed to change the sterilization dose range for its products from (b)(4) to (b)(4) as registered and approved by the Korean FDA and validate the new sterilization dose range. However, your firm has not initiated any corrective actions related to the product distributed that did not meet its validated radiation dose specification (b)(4).
b. Your firm did not follow the plan that is included in the procedure, Process Validation, QP-707 Revision 0, for the sterilization dose audit for the gamma sterilization of the GP Lancets and Safety Lancets. The plan states that the sterilization dose audit shall be performed every (b)(4) for the (b)(4), every (b)(4) for the (b)(4) if there is no non-conformity in the (b)(4), and then (b)(4) from the (b)(4) on if there is no non-conformity in the (b)(4). Your firm completed the sterilization validation in 2010 but has performed the dose audit (b)(4).
The adequacy of your firm’s response cannot be determined at this time. No documentation of the corrective action was available for review since your firm stated that a revalidation of the sterilization process will be conducted and dose audits will be conducted per procedure within six months.
2. Failure to ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, your firm did not validate the (b)(4) process for the GP Lancets and Safety Lancets.
The adequacy of your firm’s response cannot be determined at this time. No documentation was available for review since your firm stated that the (b)(4) process will be validated (b)(4).
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm did not identify corrective actions to prevent recurrence of nonconformances for Corrective and Preventive Action (CAPA) Issues #NC-11-01 and NC-12-01.
- Your firm initiated Issue #NC-11-01, dated November 28, 2011, for the lack of (b)(4). This issue was closed on February 16, 2012, after training was provided to (b)(4) that were referenced in the CAPA.
- Issue #NC-12-01, dated November 17, 2012, was initiated for the lack of proper training for (b)(4). These problems are similar to the problems identified in Issue #NC-11-01. Issue #NC-12-01 was closed on January 25, 2013, after training was provided to the (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. Your firm proposed a corrective action to revise its CAPA procedure to confirm the proper training of the (b)(4). However, your firm’s response did not consider corrective action to include an evaluation of the firm’s quality system to determine if other CAPAs were verified or validated to ensure that actions were effective and did not adversely affect the finished device.
4. Failure to maintain complaint files and 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 investigate complaints received on June 10, 2011, and June 14, 2011. These two complaints were related to the (b)(4). The reason for not investigating these complaints was not documented. The complaint procedure QP-710, Revision 2, requires an investigation of a complaint unless an investigation for a similar complaint was done previously. The complaint procedure also requires documenting the reason for not investigating a complaint.
We reviewed your firm’s response and conclude that it is not adequate. Your firm proposed a corrective action to revise its CAPA procedure, provide training to personnel, and investigate and document the complaints within (b)(4). However, your firm did not consider corrective action that would involve reviewing the complaint system for other complaints, which investigation was not performed and not documented per procedure.
Given the serious nature of the violations of the Act, lancets and lancing devicesmanufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, 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 #397800 when replying. If you have any questions about the contents of this letter, please contact: LaShanda Long, Chief, General Surgery Devices Branch at (301) 796-5465or 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