- C World KSG Corporation
- 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
FEB 18, 2016
VIA UNITED PARCEL SERVICE
Ssang Gi Kim
C World KSG Corporation
No. 2 8th Street Golden Mile Business Park
Brgy. Maduya Peza, Carmona
Dear Mr. Kim:
During an inspection of your firm located in Carmona, Philippines, on October 26, 2015, through October 29, 2015, 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 Ms. Da Young Kim, Chief Operating Officer, dated November 18, 2015, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional 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 monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b). For example:
a. Your firm's validated (b)(4) process defines the following parameters:
However, the required process parameters are not met for (b)(4) lots of contact lenses manufactured in (b)(4) and shipped to U.S. customers.
b. Your firm's "(b)(4), requires a (b)(4) be conducted with each sterilization run. However, your firm has not been performing (b)(4) test as required.
We reviewed your firm's response and conclude that it is not adequate. The response indicated that your firm will revalidate the (b)(4) sterilization process to ensure that the process can consistently produce product within specifications. The packaging process will be validated to ensure that the packaging materials can withstand sterilization exposure. The response also indicated that your firm will conduct a review of the (b)(4) test and other methods to ensure adequate validation, as well as conduct personnel training. However the response did not provide this updated validation documentation for review. Additionally, your response did not include a risk assessment for product manufactured outside of specified validation parameters.
2. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example: your firm's CAPA procedure, (b)(4), does not include requirements for verifying or validating CAPAs to ensure that such actions are effective and do not adversely affect the finished device. (b)(4) are closed; however, none of these CAPAs contain documentation indicating the CAPAs are effective. Additionally, your firm provided a CAPA log indicating eight CAPAs were initiated and closed in 2014. However, your firm does not have documentation for these eight CAPAs.
The adequacy of your firm's response cannot be determined at this time. Your firm updated (b)(4) to include the requirements for verifying or validating CAPAs to ensure that such actions are effective and do not adversely affect the finished device. The response indicated that your firm will conduct training and reviews to ensure that the CAPA verification effectiveness are adequately conducted and CAPA activites are documented. However, your firm has not provided documentation of these corrective actions.
3. 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: your firm's "Handling Product Complaints and Adverse Reaction Procedure," (b)(4), only addresses complaints concerning adverse effects. Your firm does not have a procedure for handling other types of complaints.
We reviewed your firm's response and conclude that it is not adequate. The response indicated that your firm will revise (b)(4) to include all regulatory requirements for complaints and conduct training on the revised procedure. However, the response did not include a plan to ensure past complaints are adequately evaluated and maintained in accordance with the revised procedure.
4. 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 "Internal Quality Audit Procedure," (b)(4), indicates that internal audits must be conducted in (b)(4) and the audits must be documented on the audit checklist and the audit report. However, internal quality audits, conducted in (b)(4), are not documented, as required by (b)(4).
We reviewed your firm's response and conclude that it is not adequate. The response indicated that your firm will correct the deficiencies from the (b)(4) internal audits. However, the response did not indicate your firm will evaluate the risk of releasing nonconforming product if the audits reveal quality issues.
Given the serious nature of the violations of the Act, contact lenses manufactured 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 regarding the adequacy of your firm's response and the 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.
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 (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.
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, Room 3523, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #486278 when replying. If you have any questions about the contents of this letter, please contact Daniel Walter, Chief, Foreign Enforcement Branch, at firstname.lastname@example.org
(email), +1(240)402-4020 (telephone), or +1(301)847-8138 (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 lnspectional 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.
CAPT Sean Boyd, MPH, USPHS
Office of Compliance
Center for Devices and Radiological Health
Da Young Kim
Chief Operating Officer
C World KSG Corporation
No. 2 8th Street Golden Mile Business Park
Brgy. Maduya Peza, Carmona