Inspections, Compliance, Enforcement, and Criminal Investigations

Meridian Co., Ltd. 8/19/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire A venue
Silver Spring, MD 20993

 

WARNING LETTER
AUG 19, 2014
 
VIA UNITED PARCEL SERVICE
 
In-Bum Park
CEO/President
Meridian Co., Ltd.
4F 196-35, Anyang-Dong, Manan-Gu
Anyang-Si, Gyeonggi-Do, 430-857
Republic of Korea
 
Dear Mr. Park:
 
During an inspection of your firm located in Anyang-Si, Gyeonggi-Do, Republic of Korea, on May 26 through 29, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures infrared lamps and plethysmographs. 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 your response, dated June 12, 2014, 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 receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
 
a.  Reports from customers on product malfunctions were not classified as complaints. Your firm's procedure, Customer Complaints, (b)(4) requires that product malfunctions be classified as complaints.
 
b.  Your firm did not evaluate these complaints for MDR reportability.
 
We reviewed your firm's response and conclude that it is not adequate. Your firm indicated that it will revise its complaint procedure to redefine customer complaints to include actual reports received from customers on product malfunctions and to designate an individual responsible for evaluating customer complaints for MDR reportability. However, your firm did not provide adequate documentation of implementation of its corrective actions, including your firm's revised procedure and personnel training records on the revised procedure. In addition, your firm did not perform a retrospective review of past complaints utilizing the revised procedures.
 
2.    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's CAPA procedure, Corrective and Prevention, MQP-QA-007, did not have a requirement for verifying and validating CAPA activities to ensure that such action is effective and does not adversely affect the finished device.
 
b.  Your firm generated corrective action reports for nonconformances identified during internal audits. These reports were not analyzed to identify the existing and potential causes of nonconformance. This analysis is required by part 5 of your firm's CAPA procedure.
 
We reviewed your firm's response and conclude that it is not adequate. Your firm indicated that it plans to revise its CAPA procedure to specify the requirements for verification or validation of corrective actions. However, your firm's response did not provide adequate documentation of implementation of its corrective actions, including your firm's revised procedure and personnel training records on the revised procedure. In addition, your firm did not indicate whether all CAPAs will be retrospectively reviewed in accordance with your firm's revised procedure.
 
3.    Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example:
 
a.  Your firm's purchasing control procedures, Purchasing Management, (b)(4) and Evaluation Sheet, (b)(4) exempt purchases of some components from the supplier qualification process. However, your firm's procedure did not specify which components are exempted.
 
b.  Your firm did not maintain contracts with major suppliers such as the supplier of the printed circuit boards and small components which are placed on them.
 
c.  Your firm did not establish and maintain records of acceptable suppliers, contractors, and consultants.
 
We reviewed your firm's response and conclude that it is not adequate. Your firm did not submit a description of its corrective actions for the cited deficiencies.
 
4.    Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results and to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. as required by 21 CFR 820.72(a). For example:
 
a.  Your firm's Measurement Management procedure (b)(4) requires annual equipment calibration. However, out-of-calibration equipment was used to perform final acceptance tests.
 
b.  Your firm is using (b)(4) However, the (b)(4) on these units were not calibrated.
 
We reviewed your firm's response and determined that it is not adequate. Your firm indicated that it will revise its calibration procedures to ensure that only calibrated equipment will be used for final acceptance testing. However, your firm did not provide documentation ensuring that all test equipment is properly calibrated.
 
5.    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.  Part 6.8 of your firm's design control procedure, Design and Development, (b)(4), refers only to design changes made during the design and development phase, not to design changes made to a finished device.
 
b.  Several design change forms (dated April25, 2012, July 21 , 2008 and January 31, 2008) Jacked documentation of risk analysis update.
 
c.  Your firm did not validate a design change made to the Lapex Lucia operating software from Version 1.2 to Version 1.3.
 
d.  Your firm made a design change to the label of the Lapex BCS Pro and 2000P lasers in 2007. The final approved label incorrectly indicated laser (b)(4) millimeters (mm) instead of nanometers (nm). However, your firm did not verify this design change and continued to implement the incorrect label since 2007.
 
We reviewed your firm's response and conclude that it is not adequate. Your firm indicated that your firm's design control procedures will be revised to include design changes made to a finished device and to integrate risk analysis into the design change process. However, your firm's response did not contain adequate documentation of implementation of your firm's corrective actions, including your firm's revised procedure, personnel training records and retrospective review of past design changes to ensure that the design changes conform to your firm's revised procedures.
 
Your firm indicated that it completed the validation of the Lapex Lucia operating software from Version 1.2 to Version 1.3. However, your firm did not submit adequate documentation of implementation of its corrective actions, including your firm's validation procedure used and a summary of the validation report.
 
Your firm indicated that it discarded the incorrect wavelength labels and notified its supplier about this discrepancy. However, your firm did not provide adequate documentation of implementation of its corrective actions, including a copy of your firm's correct label and retrospective examination of labels for accuracy for all modified devices.
 
6.    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, your firm was unable to provide training records for any employees.
 
We reviewed your firm's response and determined that it is not adequate. Your firm indicated that it was unable to retrieve training documentation due to facility relocation. However, your firm did not provide adequate documentation of implementation of its corrective actions to address the cited deficiencies.
 
7.    Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i).
 
For example, your firm did not validate the (b)(4) software used to maintain all quality system records, as required by your firm’s Quality Manual.
 
We reviewed your firm's response and conclude that it is not adequate. Your firm indicated that it will validate the (b)(4) software. However, your firm did not provide adequate documentation of Implementation of its corrective actions, including documentation of completed validation. In addition, your firm did not indicate whether it performed a review of other software in order to determine if appropriate validation occurred.
 
8.    Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example:
 
a.  Your firm's procedure. Inspection and Test (b)(4),  for the final inspection testing for the DPA and Lapex-2000P were missing the following information:
 
i.  The form's identification/version numbers.
 
ii.  Review and approval signatures.
 
iii.  Dates of approval.
 
b.  The process instructions for assembly of the Lapex-2000P device include the following deficiencies:
 
i.  A hand-written change was made on page 9 of 10 to part #4 (10 label, Sticker section). There was no record of who made this change, when it was made, who reviewed it, and who approved it.
 
ii.  Hand-written additions to the parts list on page 2 of 10, back case section, were made. There were no initials, dates, or approval signatures for these changes.
 
iii.  There were no operator or reviewer signatures on page 6 of 10, Front (b)(4) case section.
 
iv.  On the bottom of each page, there were no entries in the blocks for "Revision" and "Reference."
 
c.  Several design change records for the Lapex BCS Pro, dated April25, 2012, did not have signatures of reviewing and/or approving officials, or dates of approval.
 
We reviewed your firm's response and determined that it is not adequate. Your firm indicated that it will revise its procedures and conduct training. However, your firm did not provide adequate documentation of implementation of its corrective actions, including your firm's revised procedure and personnel training records on the revised procedure. In addition, your firm needs to perform corrective actions on its document control system.
 
9.    Failure to maintain device history records (DHRs) and to establish and maintain procedures to ensure that DHRs 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 this part, as required by 21 CFR 820.184. For example, at least 22 DHRs for the DPA and Lapex 2000P products did not include copies of labels or records of examination, and release of device labeling.
 
We reviewed your firm's response and determined that it is not adequate. Your firm indicated that it will revise its DHR procedures. However, your firm did not provide documentation of implementation of its corrective actions, including your firm's revised procedure, personnel training records on the revised procedure and retrospective documentation of DHRs to include labeling.
 
10.    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:
 
a.  Your firm's Internal Quality Audit procedure, (b)(4).  covers the Quality Control and Production Departments an no other quality system areas.
 
b.  Your firm did not have documentation to show what departments were covered and who performed the audits.
 
We reviewed your firm's response and determined that it is not adequate. Your firm indicated that it will revise its procedures to include coverage for all quality system areas. However, your firm did not provide adequate documentation of implementation of its corrective actions, including your firm's revised procedure, personnel training records, and retrospective documentation of quality audits in accordance with your firm's revised procedures.
 
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:
 
11.    Failure to develop, maintain and implement written MDR procedures as required by 21 CFR 803.17.
 
For example, during the inspection, your firm acknowledged that it did not have an MDR procedure.
 
The adequacy of your firm's response cannot be determined at this time. Your firm's response indicated that an MDR procedure will be developed. However, your firm did not provide adequate documentation of implementation of its corrective actions, including a copy of your firm's MDR procedure.
 
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/Forlndustrv/FDAeSubmitter/ucm107903.htm
 
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team 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.
 
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 response(s) 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 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #432302 when replying. If you have any questions about the contents of this letter, please contact: Mr. Daniel Walter, Branch Chief at 301-796-5587.
 
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, FDA483, 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.
 
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
 
 
cc
U.S. Agent
 
Samuel Kim
Meridian America Medical Inc.
14471 Redhill Ave. #E
Tustin, California 92780
Phone: 714-356-2348
Fax: 714-258-1039
Email: To_Sam_Kim@yahoo.com

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