- Shina 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|
White Oak Building 66
Silver Spring, MD 20993
AUG 23, 2016
VIA UNITED PARCEL SERVICE
691 – 1, Boheung – Lee
Woosung – Myun, Gong – Ju
Chongchungnam – Do
Gong – Ju, Korea, 32533
Dear Mr. Bang:
During an inspection of your firm located in Gong – Ju, Koreaon May 2, 2016 through May 5, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures hypodermic needles, piston syringes, and antistick syringes. 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 H.D. Cho, Director, dated May 26, 2016, 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 establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
a. Your firm opened CAPA QA-15-11-01 after receiving complaints of white sticky residue on 0.5cc Gaskets. Your firm did not document an investigation to determine the identity of the residue. Additionally, your firm did not document the verification of effectiveness of the corrective action made.
b. Your firm opened CAPA QA-16-01-02 due to finding a broken syringe. The investigation determined the silicon in the syringe barrel had not been applied adequately. The corrective action described managing the amount of silicon, but does not explain how this will be accomplished.
c. CAPA procedure SQP-14-01 and associated forms do not require that information related to quality problems is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.
We reviewed your firm’s response and conclude that it is not adequate. The response indicated the CAPA procedure and forms will be revised and staff will be trained on the revised procedure. However, the response did not indicate specific corrections to address the problems observed during the inspection. Additionally the response did not indicate:
a. Whether your firm will conduct a risk analysis for finished devices using gaskets having the residue problem.
b. How silicon in the syringe barrel will be controlled.
c. If your firm will evaluate past CAPAs for adequate investigation and verification of effectiveness and documentation of corrective actions.
d. If your firm will evaluate past CAPAs to ensure adequate dissemination of CAPA information.
2. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). For example: Design Control (b)(4), does not describe how design transfer will be controlled.
3. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example: Design Control (b)(4), does not describe that design validation shall include testing of production units under actual or simulated use conditions to ensure that devices conform to user requirements and intended uses.
4. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e). For example: Design Control (b)(4), does not require that design reviews will include an individual who is independent from the design stage being reviewed.
We reviewed your firm’s response and conclude that it is not adequate. The response indicated that the Design Control (b)(4), will be updated to include a description of how design transfer will be made; to require design validation using production units; and include design reviews requiring an individual independent from the design stage being reviewed. However, the response did not indicate whether your firm will perform:
- With respect to violation 2; retrospective reviews of design transfers to ensure that device designs were adequately transferred into production specifications.
- With respect to violation 3; Retrospective reviews of design validations to ensure testing was conducted on production units under actual or simulated use conditions and demonstrated that user needs and intended use requirements were met.
- With respect to violation 3; An evaluation of current design review activities to ensure an independent individual was present for the review and remediate as necessary.
5. 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: the (b)(4), for Safety Syringe Lot 60215, was (b)(4) during the process. According to the validation requirement, (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. The response indicated your firm will revise (b)(4), Rev. 5, and Procedure SQP-090-05, Rev. 3, and train personnel on the revised procedures. The response indicated your firm will investigate the possibility of modifying the (b)(4) in order to (b)(4). However, the response did not include a risk evaluation for products sterilized using out of specification (b)(4). Additionally, your firm did not perform a retrospective review of validated processes to determine if they are operating within the validated ranges.
6. Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j). For example: the insulin pen needle product (K113186) does not have a DHF.
The adequacy of your firm’s response cannot be determined at this time. The response indicated your firm will revise the “Design Control Procedure”, SQP-07-02, Rev 0, to include the appropriate contents of the DHF and train personnel on the revised procedure. The response also indicated your firm will retrospectively review DHF for the insulin pen needle. Your firm will review all products to ensure they have a DHF and remediate if necessary. However, no documentation has been submitted for FDA review.
Our inspection also revealed that the Hypodermic Single Lumen Needle device is 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 regarding the devices 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 deviations include, but are not limited to:
7. Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure, titled QUALITY PROCEDURE, MDR, DOC. No. SQP-01-05, REV No. 0, REV DATE: 2013.01.10, the following issues were noted:
a. “QUALITY PROCEDURE,” Rev No. 0, 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: the procedure omits definitions of the terms “become aware,” “caused or contributed” and “MDR reportable event” from 21 CFR 803.3. The exclusion of the definitions for these terms from the procedure 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. “QUALITY PROCEDURE,” Rev. No. 0, does not 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: the flowchart in your firm’s procedure does not reference a process for investigating events identified as MDRs to ensure that MDRs are submitted to FDA within the required reporting timeframes, as required under 21 CFR 803.17(a)(1).
c. “QUALITY PROCEDURE,” Rev. No. 0,does not establish internal systems that provide for timely transmission of complete medical device reports. For example: although the procedure includes references to 30 day and 5 day reports, it does not specify calendar days and work days, respectively.
d. “QUALITY PROCEDURE,” Rev. No. 0,does not describe how the firm will address documentation and record-keeping requirements, including:
i. 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.
ii. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
Your firm’s procedure includes references to baseline reports and annual certifications. Baseline reports and annual certifications are no longer required and we recommend that all references to a Baseline Report and annual certification be removed from your firm’s MDR procedure (see respectively: 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).
Your procedure includes a reference to submit MDRs to FDA using the following address: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002. Please note that effective August 14, 2015, MDRs must be submitted electronically and paper submissions are not being accepted, except under special circumstances, directed by FDA. Your firm should adjust its MDR procedure accordingly 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 should 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: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR%E2%80%93ElectronicMedicalDeviceReporting/default.htm
The adequacy of the response dated May 27, 2016, cannot be determined at this time. Your firm promised to revise its MDR procedure to address the items listed in the FDA 483 and included an action completion date of July 30, 2016. This documentation has not yet been received for review. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy.
Given the serious nature of the violations of the Act, hypodermic needles, piston syringes, and antistick syringesmanufactured 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.
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 responses 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 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #501643 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) 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
350 Highway 7
Excelsior, MN 55331