- Infopia Co., Ltd.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
JULY 10, 2014
VIA UNITED PARCEL SERVICE
Mr. Andrew Koh
Infopia Co., Ltd.
132 Anyangcheondong-ro Dongan-Gu
Anyang-si, Gyeinggi-do, KR
Dear Mr. Koh:
During an inspection of your firm located in Anyang-si, South Koreaon February 17, 2014 through February 20, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Easygluco (glucose), Element (glucose), GluNEO (glucose), GluNEO Lite (glucose), Healthpro (glucose), Hemocue HbA1c 501 (hemoglobin), LipidPro (lipid), and LipidPlus (lipid). 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 C. W. Cho, Assistant Manager of Quality Assurance Team dated March 5, 2014 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 verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished product, as required by 21 CFR 820.100(a).
For example: Your firm issued Corrective Action Report CA-ETC-2010-06-02 on 6/5/2010. This Corrective Action Preventive Action (CAPA) was in response to your firm’s mislabeling of Control Solution lot number CN9KB17 which was released for distribution on 2/22/2010. Your firm conducted an investigation and implemented corrective actions. Your firm filed MDR 9056376-2010-0001 on 5/19/11 and issued a product field correction (notification) to your customers for the removal of glucose control solution lot CN9KB17 from the market. The preventive part of the CAPA CA-ETC-2010-06-02 was for the training of personnel. Corrective Action Report CA-ETC-2010-06-02 was closed on 6/28/2010. Your firm did not document in the CAPA report verification or validation of the implemented corrective actions.
Approximately one (1) year later, your firm issued Corrective Action Report CA-CC-2011-06-01 on 6/10/2011. This Corrective Action Preventive Action (CAPA) was in response to your firm’s mislabeling of Control Solution lot number CN9LA06 which was released for distribution on 1/31/2011. Your firm conducted an investigation and implemented corrective actions. Your firm filed MDR 9056376-2011-00001 on 6/10/11 and issued a product field correction (notification) to your customers for the removal of glucose control solution lot CN9LA06 from the market. The preventive part of the CAPA CA-CC-2011-06-01 was for the training of personnel and (b)(4). In addition, your firm’s distributor, (b)(4). Corrective Action Report CA-CC-2011-06-01 was closed on 6/28/2011. Your firm did not document in the CAPA report verification or validation of the implemented corrective actions.
In addition, your firm has revised the overall Corrective and Preventive Action procedure (b)(4). This (b)(4) effective 12/27/2013. This procedure does not clearly detail each of the steps between the identification (b)(4) of the established Corrective Actions and Preventive Actions (CAPA).
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided an updated Quality Procedure for Corrective and Preventive Action Regulation and a training report for the new CAPA management process. Your firm also provided a comparison of your previous and new procedures showing the changes made between 2010 and 2014. However, your firm has not provided a plan to verify and validate the corrections and corrective and preventive actions for the two CAPAs mentioned above. In addition, your firm did not provide documentation to demonstrate that you completed a retrospective review of all CAPAs to determine whether any corrections or corrective actions should be applied to other CAPAs.
2. Failure to ensure that when results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
For example: Your firm manufactures solutions to be used with your glucose meters termed glucose control solutions. These solutions are standards to verify that the glucose meter is operating correctly at low range, normal range, and high range of its functionality. These solutions are manufactured at your firm using procedure (b)(4). This procedure indicates the (b)(4). Your firm conducted a performance test to determine (b)(4) in the glucose control solution. The results are documented (b)(4). The documentation results for (b)(4) needed for the (b)(4) indicates that the performance test standards for the (b)(4) were all below the desired specification. Your firm’s procedure (b)(4) states that the (b)(4) is to be (b)(4). The documented test results in the (b)(4) indicates that the (b)(4) for the glucose control solution will not give the results stated by your firm’s specifications. Upon review of the raw data taken during the performance test, those test results indicate that (b)(4) was within the (b)(4) specification. Your firm failed to detect during review and subsequent approval of (b)(4) that the incorrect test results were documented in the report.
We reviewed your firm’s response and conclude that it is not adequate. According to your firm, for the instance noted, the (b)(4) raw data was correct but was transcribed incorrectly and not properly reviewed. Your firm revised your Process and Equipment validation procedure. You implemented a quality form for the raw data and implemented review procedures for the validation report, including test data. Your firm has also implemented staff training on data management. However, your firm has not provided verification evidence to demonstrate that the updated Process and Equipment validation procedure adequately corrects and prevents recurrence of the quality problem with review and approval of incorrect results. In addition, your firm did not provide evidence that you completed a retrospective review and investigation of other process validations to determine whether any corrections or corrective actions should be implemented.
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.
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 (which must address systemic problems) 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. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #432756 when replying. If you have any questions about the contents of this letter, please contact: James L. Woods at 301-796-6225 or fax 301-847-8513.
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.
Office of In Vitro Diagnostics and
Center for Devices and
Close Out Letter