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Department of Health and Human ServicesWARNING LETTER
VIA UPS EXPRESS
FEB 3 2011
Mr. Tsutomu Sugahara
President
OEM Systems Co., Ltd.
84, Mekawa Makishima-Cho
Uji-Shi Kyoto, Japan
Dear Mr. Sugahara:
During an inspection of your firm located in Uji-Shi Kyoto, Japan on October 25, 2010 through October 28, 2010, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures the iMark Microplate Reader, the VARIANT II Hemoglobin Testing System, and the VARIANT II TURBO Link. 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action and to document all the activities and results associated with corrective and preventive action, as required by 21 CFR 820.100.
For example:
a. The procedure No. GS-016/Edition 4: “Corrective and Preventive Action Procedure” does not include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service reports, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. The Corrective and Preventive Action Procedure (GS-016/Edition 4) does not define requirements for investigating the cause of nonconformities; identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems; verifying or validating the corrective and preventive action; implementing and recording changes in methods and procedures; and ensuring that information related to quality problems is disseminated to those directly responsible for assuring the quality of affected products. In addition, procedure GS-016/Edition 4 does not define that appropriate statistical methodology shall be employed where necessary to detect recurring quality problems.
b. Your firm’s CAPA (corrective and preventive action) report No. (b)(4) was initiated as a result of a customer complaint stating that the VARIANT II, VNBS tubing connector at the degasser was broken. The CAPA report No. (b)(4) was closed on 07/08/2010; however, the firm was not able to provide documentation of verification or validation activities to demonstrate that the corrective action did not adversely affect the finished device. In addition, CAPA report No. (b)(4) was initiated as a result of a customer complaint reporting a low F-value on the VARIANT II. The CAPA report No. (b)(4) was closed on 07/06/2010; however, the firm was not able to provide documentation of any verification or validation activities to demonstrate that the corrective action was effective.
2. Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90.
For example:
a. The Nonconforming Product Control Procedure, GS-013 Edition 4, dated 10/12/2010 does not define the responsibility for review and the authority for the disposition of nonconforming product. In addition the procedure GS-013 edition 4, does not define rework activities, that include requirements for retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, and rework evaluation activities, including determination of any adverse effect from the rework upon the product, shall be documented in the device history record.
b. Your firm completed a repair activity of changing the light fiber for the iMark Serial No. (b)(4) as a result of a nonconformance identified on 10/13/2010. However, your firm was not able to provide the work instructions for this repair as required by the firm’s procedure No. GS-013/Edition 4: “Nonconforming Product Control Procedure”. In addition, your firm completed a repair activity on the VARIANT II VCS Serial No. (b)(4) as a result of a nonconformance identified on 10/18/2010. However, your firm was not able to provide the work instructions for this repair as required by the procedure GS-013/Edition 4..
3. Failure to establish and maintain adequate procedures for verifying the device design. The results of design verification shall confirm including identification of the design, method(s), date, and individuals performing the verification shall be documented in the design history file, as required by 21 CFR 820.30(f).
For example: Your firm has no documentation of design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification of the change in specification ID: (b)(4) for the (b)(4) of the VARIANT II TURBO Link in the DHF of this device. In addition, the firm did not adequately document the verification method that was followed during design verification activities for the TURBO HST’s (TURBO Link) capability of (b)(4) test, dated 12/28/2006.
4. Failure to establish and maintain adequate procedures for validating device design under defined operating conditions on initial production units, lots, or batches or their equivalents and to document the design, method(s), date, and individuals performing the validation, as required by 21 CFR 820.30(g).
For example: The procedure No. DS-001/Edition 9: “New Product Development Procedure” states that product design validation is performed by (b)(4) but it does not define the procedures for validating a device design or the requirements for documenting the design, method(s), date, and individuals performing the validation. In addition, the firm was not able to provide documentation to demonstrate that the VARIANT II TURBO Link units with serial numbers (b)(4) to (b)(4) that were sent to a (b)(4) for design validation were initial production units, lots, or batches or their equivalents.
5. Failure to adequately ensure that, when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to an established procedure, as required by 21 CFR 820.75(a).
For example: Your firm completed a (b)(4) process on 5/14/2009 and the process validation was conducted on 5/16/2009 before the validation procedure No. PS-396/Revision 1: “(b)(4) Lead-Free Soldering Operation Validation Procedure” was approved on 5/26/2009. In addition, your firm was not able to provide documentation of review and revalidation of the change in the (b)(4) process to a (b)(4) operation. The process validation protocols and/or reports do not define the conditions for revalidation when changes or process deviations occur.
6. Failure to establish and maintain adequate 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: The procedure No. DS-005/Edition 5: “Design Change Control Procedure”, dated 07/01/2010, does not define the procedures for validation or where appropriate verification of design changes before implementation and it does not define procedures for pre-production design changes. In addition, the firm was not able to provide design change documentation including validation or where appropriate verification, review, and approval for a change in specification (b)(4) for the power consumption of the VARIANT II TURBO Link from less than (b)(4) to less than (b)(4).
7. Failure to establish and maintain adequate procedures for quality 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: The procedure No. GS-010/Edition 6: “Internal Audit Procedure”, dated 09/01/2010, does not define that the dates of quality audits and reaudits should be documented. In addition, the quality audit procedure does not define that corrective action(s), including a reaudit of deficient matters, be taken when necessary.
8. Failure to adequately establish and maintain procedures to control documents required by 21 CFR Part 820, as required by 21 CFR 820.40.
For example: The procedure No. GS-002/Edition 4: “Document Control Procedure”, dated 11/25/2008, does not provide for documentation in change records of a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective. In addition, your firm did not adequately maintain records of document changes.
9. Failure to establish and maintain adequate procedures to ensure that sampling methods are adequate for their intended use and failure to ensure that when changes occur the sampling plans are reviewed, as required by 21 CFR 820.250(b).
For example: The firm has no valid statistical rationale for the sampling plans used to select samples during the lead-free soldering operation validation procedure.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)) Also, U.S. federal agencies are advised of the issuance of all 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. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to:
James L. Woods
Deputy Director for Patient Safety and Product Quality
Food and Drug Administration
Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH
WO66 RM5688
10903 New Hampshire
Silver Spring, MD 20993
If you have any questions about the content of this letter please contact: Ileana Elder at (301) 796-6143.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Sincerely yours,
/s/
Alberto Gutierrez
Director
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and
Radiological Health
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