| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
SEPT 14, 2016
VIA UNITED PARCEL SERVICE
Neo Vision Co., Ltd.
129-1 Donghwagongdan-Ro, Munmak-Eup
Wonju-Si, Gangwon-Do 220801
Republic of Korea
Dear Mr. Kim:
During an inspection of your firm located in Wonju-Si, Gangwon-Do, Republic of Korea on May 9, 2016, through May 12, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures daily wear soft 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 and reviewed responses from your firm dated May 25 and 27, 2016, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm.
Your firm’s responses dated June 27, 2016, July 14, 2016, and August 15, 2016, to the Form FDA 483 (FDA 483) were not reviewed because they were 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 establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm has design control procedures, Planning and Development Management Procedures, Document #NVQP-730, Revision 0, dated September 1, 2008, and Revision 1, dated February 3, 2014. However, your firm has not implemented design controls for the Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lenses (cleared under 510(k) #K142275 on October 7, 2014). Your firm did not conduct design verficaiton/validation for these devices. Your firm also has not established the design history file (DHF) for the Neo Cosmo Soft Contact Lenses.
We reviewed your firm’s responses and conclude that they are not adequate. The responses indicated that the design controls for contact lenses were implemented in 1993, prior to FDA’s implementation of the Quality System (QS) regulation. The responses indicated that your firm was not aware of the design control requirements per the QS regulation, and will establish design control procedures, conduct employee training, and establish the DHF for the Neo Cosmo Soft Contact Lenses. However, your firm should also review other devices and evaluate if similar corrective actions are necessary. Additionally, an evaluation should be conducted to determine if lack of design controls could have resulted in the release of nonconforming products. If so, corrective actions should be taken to mitigate any adverse effect on the end user, where appropriate.
2. 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. Your firm’s process control procedure, Q.C. Process Flow Chart, Document #NVQI-110, Revision 3, requires (b)(4) be performed for each lot and testing results to be documented in Form #NVQP-830-2. However, a review of eleven device history records (DHRs) (e.g., DHRs #863150629, #863151211, #864160406, and eight additional records) from 2015 through 2016, pertaining to the soft contact lenses manufactured for the U.S. market, revealed your firm has not documented the data to demonstrate that the required testing is performed.
b. (b)(4) Per Raw Materials Work Instruction, Document #NVQI-210, Revision 2, a (b)(4) is required to allow full production to occur. A batch is only approved when the (b)(4) are successfully completed for (b)(4). However, your firm’s work instruction does not require that (b)(4). Your firm also has not established procedures to verify that (b)(4).
We reviewed your firm’s responses and conclude that they are not adequate. The responses indicated that lack of training on Form #NVQP-830-2 is the root cause for lack of documentation. Your firm conducted employee training on this form and provided training records. However, your firm should also conduct an evaluation to determine if lack of training/documentation on the required testing results could have resulted in the release of nonconforming products. If so, corrective actions should be taken to mitigate any adverse effect on the end user, where appropriate. In addition, your firm should evaluate whether employees are adequately trained on other applicable forms.
Regarding (b)(4) raw material, the responses indicated the (b)(4) testing is performed on an ongoing basis. However, the process is not described in a written procedure. Your firm provided a work instruction (NVQP-830) that included all aspects of the (b)(4)inspection, and employee training records on the work instruction. The work instruction included validation (b)(4) of the lens material. However, your firm should also provide a summary of the validation results. Your firm should conduct an evaluation to determine if the lack of a written procedure could have resulted in the release of nonconforming products. If so, corrective actions should be taken to mitigate any adverse effect on the end user, where appropriate.
3. Failure to establish and maintain procedures to ensure that device history records (DHR’s) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of 21 CFR 820, as required by 21 CFR 820.184. For example, your firm has not established DHR procedures. Your firm does not have complete DHRs for eleven DHRs from 2015 through 2016 (pertaining to the soft contact lenses manufactured for the U.S. market). Additionally, none of the eleven DHRs (e.g., DHRs #863150629, #863151211, #864160406, and eight additional records) included or referred to the location of the primary identification label and the labeling used for each production unit.
We reviewed your firm’s responses and conclude that they are not adequate. The responses indicated that the DHRs are compiled with DHRs for other contact lenses. Therefore, the records are located in separate locations for specific steps. Your firm provided the procedure, NVQI-640, that requires creating a single DHR for U.S. products. However, your firm should also include employee training on the procedure. Additionally, your firm should indicate whether it has implemented the procedure and established DHRs for the products sold in the U.S.
Our inspection also revealed that your firm’s 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. Significant violations include, but are not limited to, the following:
4. Failure to develop, maintain and implement written MDR procedures as required by 21 CFR 803.17. For example, your firm’s MDR procedure, Claim Control Procedure, Document #NVQP-810, Revision 1, dated May 6, 2016, does not:
a. Establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
b. Establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
i. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
ii. The procedure, as written does not specify who makes the decision for reporting events to FDA.
iii. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
c. Establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
i. The circumstances under which your firm must submit initial 30 days, supplemental or follow-up, 5 day report and the requirements for such reports.
ii. The procedure does not include a reference for the submission of MDR reportable events using the mandatory 3500A or electronic equivalent.
iii. Although the procedure includes references to 30 day, 5 day reports, it does not specify calendar days and work days, respectively.
d. Describe how it will address documentation and record-keeping requirements, including:
i. Documentation of adverse event related information maintained as MDR event files.
ii. Information that was evaluated to determine if an event was reportable.
iii. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
iv. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
We reviewed your firm’s responses and conclude that they are not adequate. Your firm’s revised MDR procedure, Quality Management Procedure - Medical Device Report, Document NVQI-650, Revision 0, dated July 12, 2016, does not address the deficiencies cited under items 4(a), 4(b)(ii), and 4(c)(iii).
Your firm should adjust its MDR procedure to include a process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR) published in the Federal Register on February 14, 2014. In addition, your firm will need to establish an eMDR account in order to submit MDRs electronically. Information about the Final Rule for eMDR and the eMDR set-up process can be found on the FDA website at:
Given the serious nature of the violations of the Act, daily wear soft contact lensesmanufactured 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 responses 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, Rm 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Refer to CMS case #506797 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Branch Chief, Foreign Enforcement Branch at email@example.com (email) or +1-240-402-4020 (telephone).
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.
CAPT Sean M. Boyd, MPH, USPHS
Deputy Director for Regulatory Affairs
Office of Compliance
Center for Devices and Radiological Health
Kelly Medical Consulting
27001 La Paz Road, Suite#314
Mission Viejo, CA 92691