Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
NOV 13, 2012
VIA UNITED PARCEL SERVICE
Jong-Gu Park, PhD
Chief Executive Officer
Mi Gwang Contact Lens Co., Ltd.
#116-2, Hyeopsek-ri, Namcheon-myeon
Republic of South Korea
Dear Dr. Park:
During an inspection of your firm located in Gyeongsan-si, Gyeongsanbuk-do 1234, Republic Of South Korea, on July 02, 2012, through July 05, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures contact lenses. 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 July 17, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations 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 verifying or validating corrective and preventive action to ensure that this action is effective and that it does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
For example, CAPA 110321-2 involved a return of Eyedia Clearcolor Bella contact lenses for bubbles. The corrective action involved increasing inspection and training for the defect. Also, CAPA 111109-1 involved product labeled with the incorrect contact lens power. The corrective action involved additional inspection of the labeling and training. However, your firm did not confirm by examination and provision of objective evidence that its specified requirements have been fulfilled.
We reviewed your firm’s response and conclude that it is not adequate. Your firm failed to provide a systemic corrective action, such as performing a review of CAPAs to ensure that verification of the effectiveness of current CAPAs is being done. The Non-conforming Product Management procedure, K-QUA-SOP-005, is being revised and will cross reference your firm’s Global Corrective and Preventive Action procedure, GSP-008, for identifying the potential corrective and preventive actions. However, your firm’s response does not explain what the revisions to the procedure will entail and how the revisions will address the observation. Additionally, your firm did not submit documentation to include evidence of implementation of the revised procedure and evidence that employees were trained on the new Global Corrective and Preventive Action GSP-008 procedure, or that such implementation and training would correct this observation.
2 Failure to establish and maintain adequate procedures for verifying the device design to confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, methods, the date, and the individuals performing the verification, shall be documented in the design history file (DHF), as required by 21 CFR 820.30(f).
For example, the results of the test product design (design verification) identifies that some lenses were not acceptable for (b)(4) . The documentation of the results does not identify the (b)(4) of the defect. The test results report concludes, “(b)(4)” and was accepted. The results also indicate that the (b)(4). There is no documentation that these corrections were made and that the design verification for the lens (b)(4) was found acceptable. Additionally, there was no documentation in the DHF to confirm that the design output met the design input requirements.
The adequacy of your firm’s response cannot be determined at this time. The Design and Development procedure, K-RND-SOP-001, was developed and approved on July 13, 2012, and training was scheduled to be conducted on July 16, 2012. K-CAPA-2012-002 was issued to your firm’s Research Development Department to resolve this observation and an engineering study will also be conducted on the types of lenses to confirm the acceptable level and parameters for K-CAPA-2012-002. The engineering study was developed and approved on July 13, 2012. The Design Verification for Model A/Comfort 38 Contact Lens procedure was also revised and approved on July 13, 2012.
Your firm did not submit documentation to include evidence why the revision of the procedures was being done and how the revision will prevent the problem from reoccurring. Also, your firm failed to submit documentation to support implementation of the new procedures and documentation to support that the employees were properly trained on the new procedures.
3. Failure to establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g). For example, your firm did not validate the device design for the intended use of its Model A/Comfort 38 contact lens.
Your firm’s response dated July 17, 2012, does not specifically address this issue, because it was not listed on the FDA 483.
4. Failure to establish and maintain adequate procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). For example, the firm’s Design and Development Procedure, MQP07, did not include procedures for design transfer.
Your firm’s response dated July 17, 2012, does not specifically address this issue, because it was not listed on the FDA 483.
5. Failure to develop, conduct, control, and monitor production processes to adequately ensure that the device conforms to its specifications, as required by 21 CFR 820.70(a).
For example, the (b)(4) process is set up and a test article is made and tested for (b)(4). The acceptance of the testing to demonstrate that the system is effective was not documented. Also, the (b)(4) machine parameters, including (b)(4) settings are not documented for processing.
The adequacy of your firm’s response cannot be determined at this time. The (b)(4) Process Procedure, K-PRO-SOP-006, was being developed to address the recording of the machine setting parameters and acceptance testing records. There is no documentation that these corrections were made and that the (b)(4) Process Procedure K-PRO-SOP-006 was found acceptable. Your firm planned to have the (b)(4) Process Procedures K-PRO-SOP-006 completed by July 30, 2012. Your firm further explained that K-CAPA-2012-006 was to be issued to the Production Department in order to conduct an investigation and develop a proper corrective action on all process machines and equipment of the above non-conformances. However, your firm did not submit documentation to support the implementation of the new procedures and documentation to support that the employees were properly trained on the new (b)(4) Cutting Process Procedure, K-PRO-SOP-006.
6. Failure 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 investigator specifically requested a copy of your firm’s complaint handling procedure and was told that there was no such procedure. Your firm provided its Correction and Precaution Measure procedure, MQP14. The procedure does not address how your firm will maintain complaint files and procedures for complaint handling by a formally designated unit.
The adequacy of your firm’s response cannot be determined at this time. The Complaint Handling SOP, K-QMS-SOP-007, was developed, approved, and implemented on July 10, 2012. Training on this procedure was conducted the same day. However, your firm did not submit documentation to support the implementation of the new procedures and documentation to support that the employees were trained on the new procedures.
7. Failure to establish and maintain adequate procedures for quality audits, to 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. These quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22.
For example, the audit plan for your firm’s 2011 audit did not follow the audit matrix described in your firm’s Global Internal Quality Audit/GSP-009 procedure, to ensure that all areas of your firm’s quality system are audited. The matrix provides specific guidance on the processes that should be covered, which include: (b)(4). However, the audit plan for 2011 does not specify that all processes were covered. There is no planning to ensure that identified processes of the matrix will be considered or planned so that they are covered at the frequency described in your firm’s GSP-009 procedures.
The adequacy of your firm’s response cannot be determined at this time. The training on Global Internal Quality Audit GSP-009 was conducted on July 9, 2012, and Internal Audit Plans for 2012 have been prepared to cover all requirements per the GSP-009 audit matrix. In addition, your firm stated that adequate time frames for the required audit activities are also being identified and scheduled accordingly. However, your firm did not submit documentation to support the implementation of the new procedures and documentation to support that the employees were properly trained on the new procedures.
Our inspection also revealed that your firm’s Polymacon Contact Lenses 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 (MDR) Regulation. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17(a)(1). For example, after reviewing your firm’s MDR procedure titled “Clearlab US FDA Medical Device Reporting,” Document Number K-REG-SOP-003, Version 01 dated April 4, 2012, the following issues were noted:
1. Document Number K-REG-SOP-003, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
a. Section 2.3 states, “This procedure is applicable to any potential reportable adverse events associated with Mi Gwang Contact Lens Co. Inc., Ltd.’s product which occurred within the United States and have met the relevant reporting criteria.” The procedure does not reference a process for identifying and evaluating events occurring outside the United States (U.S.) as potentially reportable to FDA. If an event occurs in a foreign country, it may be reportable under the MDR regulation if the event involves a device that is the same or similar to a device that has been cleared or approved for marketing in the U.S. By not considering events that occur outside of the U.S., potentially reportable MDRs may not be identified and evaluated for MDR decision making and submission to FDA as required by 21 CFR 803.50 and 21 CFR 803.53.
2. Your firm’s procedure includes references to baseline reporting and annual certification, which are no longer required. We recommend that all references to Baseline Reports and Annual Certification be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008; and Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting, Annual Certification, Final Rule, respectively).
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications based on the information noted above, it may contact the Reportability Review Team of the MDR Policy Branch by email at ReportabilityReviewTeam@fda.hhs.gov.
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 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, Room 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #348781 when replying. If you have any questions about the contents of this letter, please contact: Ronald Swann, Chief, Dental, Ear, Nose, Throat, and Ophthalmic Device Branch at 301-796-5770 or (fax) 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