| Public Health Service Food and Drug Administration |
10903 New Hampshire Avenue |
Department of Health and Human ServicesDEC 15, 2010
WARNING LETTER
Via United Parcel Service
Allen Lee
President
Innovative Medical Manufacturing Co.
107, Lane 181, Sec. 1, Yong Jane Rd.
Chunan, Miaoli 350, Taiwan
Refer to CMS No. 141010 when replying to this letter.
Dear Mr. Lee:
During an inspection of your firm located in Chunan, Taiwan on August 8 through August 12, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the EZ Stabilizer and EZ connect for Vidacare, San Antonio, Texas; Infiltration Tubing with single spike for Total Vein Systems, Houston, Texas; and owns the 510(k) for a Hypodermic needle set and a Dental irrigation tubing set. 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 design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed, and to ensure the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the Design History File, as required by 21 CFR 820.30(g).. For Example:
The Design Validation section of the Innovative Medical Manufacturing (IMM) hypodermic needle set Design History File (DHF), revealed that a formal clinical trial is not required to validate safety and effectiveness of the device.
The file stated that since the design is commonly used in the market the “SE comparison” has confirmed the conformity of approved product and ISO standards. Although design verification activities were conducted, the DHF did not contain documents to show initial production units were evaluated under defined operating conditions to ensure that devices conform to user needs and intended uses.
The Design History File for the IMM dental irrigation sets state the irrigation sets are equivalent to the predicative device for use in very simple and common procedures. Therefore, no design validation tasks are needed. Although design verification activities were conducted, the DHF did not contain documents to show initial production units were evaluated under defined operating conditions to ensure that devices conform to user needs and intended uses.
A follow up inspection will be required to assure that corrections are adequate. We will contact the appropriate people and request an establishment re-inspection. An FDA trip planner will be in touch with you to arrange a mutually convenient date for this inspection.
You should take prompt action to correct the violation addressed in this letter. Failure to promptly correct this violation 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 violations, or similar violations, 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. Please provide a translation of documentation not in English to facilitate our review.
Refer to CMS No. 141010 when replying to this letter. Your response should be sent to: Ms. Valerie A. Flournoy, General Hospital Devices Branch Chief; Division of Enforcement A, Office of Compliance; Center for Devices and Radiological Health, Food and Drug Administration. WO66-3526; 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993. If you have any questions about the content of this letter please contact: Dr. M. Isabel Tejero at +1 (301) 796-5322 or by facsimile at +1 (301) 847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations 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 violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/s/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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