Sometech Incorporated 11/26/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
November 26, 2012
VIA United Parcel Service
Mr. Hee-Bong Yang
152-050 2nd Floor
Byuksan Digital Valley III
212-13 Gurodong, Gurogu, Seoul
Korea, Republic of (South)
Dear Mr. Yang:
During an inspection of your firm located in Seoul, Republic of South Korea, on April 23, 2012, through April 26, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical imaging equipment and high-frequency surgical instruments. 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 are intended 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 (C.F.R.), Part 820.
We acknowledge your firm’s partial responses, dated July 19, 2012, and October 23, 2012, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (Form FDA 483), which was issued to you on April 26, 2012. These responses promised corrections of the observations discussed at the conclusion of the inspection. Please note that additional violations that were discussed with you during the inspections are also included in this letter, even though they were not listed on Form FDA 483. Please provide a comprehensive response that addresses all of the violations, which include, but are not limited to, the following:
- Failure to establish and maintain adequate procedures for implementing corrective and preventative actions, as required by 21 CFR 820.100(a). For example, CAPAs (b)(4) initiated since the last inspection, were reviewed and found deficient in that all required information regarding the CAPA investigations was not included. Additionally, your firm has not completed the following as required by its Corrective and Preventive Action Procedure SQP14A 2011.07.29(8):
a. analyzed quality data to identify existing and potential causes of nonconforming product or other quality problems;
b. used appropriate statistical methodology, where necessary;
c. identified actions needed to correct and prevent recurrence of nonconforming product and other quality problems; and
d. verified and/or validated corrective and preventive actions.
- 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 Customer Complaint Management Procedure defines complaints as, “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” Complaints and reportable device malfunctions documented in Service Reports (b)(4) were received since the last inspection, but:
a. were not considered complaints; were not processed through your firm's complaint handling process; did not include any documentation ensuring the complaints were evaluated to determine whether they represent an MDR reportable event; and
b. did not include the dates the complaints were received; any device
identifications and control numbers used; the names, addresses, and phone numbers of the complainants; the dates of the investigations; and any replies to the complainants.
- Failure to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example:
a. The Device History File did not include the dimensions of the (b)(4) following a design change to a (b)(4) dated “11/12/2011,” in response to a customer complaint documented in CAPA (b)(4) as required by Design Change Notification Document SQP04-3 (Rev.4).
b. A design change for the (b)(4), implemented because of CAPA (b)(4), does not have a signature in the “checked” and “approved” boxes as required.
- Failure to establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met, as required by 21 CFR 820.80(c). For example, the Procedure, Processing and Process Inspection Check Sheet is not being followed for Lot number (b)(4), Production Order and History Card. The Production and Final Inspection sections for lot (b)(4) and the start date for lot (b)(4) were not filled in as required.
- 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, Mr. Young-Soo Seol, your firm’s Production/QC General Manager, indicated that the quality audit plan for (b)(4) and (b)(4) did not include Part 820, Quality System regulation.
- Failure to establish and maintain adequate procedures to ensure that Device History Records 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, the Dr. Oppel ST-501 device history record, lot # (b)(4); device history record for The LVT-1OO(BIOS), lot # (b)(4); device history record, lot # (b)(4); and device history record for LVT-250, lot # missing, serial numbers (b)(4):
a. do not include or reference acceptance records, which demonstrate that the device was manufactured in accordance with the DMR; and
b. do not include or reference the primary identification label and labeling used for each production unit.
- Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example:
a. During the walk-through of the first production room, the investigator collected a copy of a build work sheet for an employee posted above her workstation. The investigator asked for her training records to confirm that she was trained in assembly of the subcomponent (b)(4) shown on the work sheet. She was not trained to assemble this sub-component. The investigator asked if she had been trained in the quality policy. Mr. Young-Soo Seol, your firm’s Production/QC General Manager, indicated that her training record did not contain training for the quality policy.
b. The investigator also reviewed the training record for another employee and found that she had not been trained in the quality policy.
- Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40. For example, Document Control Procedure SQP05, dated “2010/03/10”, (8) Section #3.4.1, states that once quality documents are approved, they should be recorded on quality management form SQP05-2 (Rev1). When document QC SQP05-2 (Rev 1) was changed in 2011, it should have been recorded on the management document form, SQP05-3 (Rev 1); however, the change is dated 2012-02-06. Document QC form SQP05-3(rev1) is missing the date next to the QC field.
We note that we also inspected your facility on November 1, 2010, through November 4, 2010. That inspection resulted in an 11-item Form FDA 483. Observations 1, 2, 3, 4, 5, 6, 8, 9, and 10 were not corrected. CAPAs were not completed for these observations. Changes were made to your firm’s procedures, but there was no evidence of implementation. Deficiencies in files and records for these observations were not corrected.
Given the serious nature of the violations of the Act, your firm will remain on import alert until the violations listed in this letter and the Warning Letter are corrected and verified in a follow-up inspection.
Please notify this office in writing within thirty 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 (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, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case #164372 when replying. If you have any questions about the contents of this letter, please contact: LaShanda Long, Branch Chief, General Surgery Devices Branch at 301-796-5770 or 301-847-8137.
Steven D. Silverman
Office of Compliance
Center for Devices and