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U.S. Department of Health and Human Services

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Enforcement Actions

Copious International, Inc 9/25/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, MD 20993

WARNING LETTER

SEPT 25, 2012


VIA UNITED PARCEL SERVICE

Mr. Wen-Tau Liu
Chairman of the Board
Copious International, Inc.
No. 20, Alley 1, Lane 217, SEC. 3 Chung Shiao E. Rd.
Taipei, Taiwan
China

Dear Mr. Liu:

During an inspection of your firm located in New City Area, Heyuan, Guangdong, China, on May 14, 2012, through May 17, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgeon caps and gowns, isolation gowns, and nurse hats.  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.

Our inspection revealed that the surgeon caps and gowns, isolation gowns, and nurse hats manufactured by your firm 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 devices that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR 803 - Medical Device Reporting.  We received a response from He Peiying, Quality Assurance Manager, dated June 1, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm at the conclusion of the inspection.  We address this response below, in relation to each of the noted violations.  These violations include, but are not limited to, the following:

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. 

For example, your firm does not have an approved or implemented MDR procedure.  When the MDR procedure was requested during the inspection, Ms. He Peiying, your firm’s Quality Assurance Manager, stated that your firm had no MDR procedure. 

We reviewed your firm’s response and conclude that it is not adequate.  Your firm’s response stated that it will be developing a procedure “according to the requirements of 21 CFR 803 – MDR procedure,” by July 30, 2012.  However, your firm still has not provided the newly developed MDR procedure to FDA for review.  Also, evidence indicating that your firm reviewed and determined if any of the events, historical complaints, and/or historical service reports reported to your firm should have been reported to FDA as a MDR, was not provided.  Lastly, evidence indicating that applicable employees were trained on the updated MDR procedure prior to implementation, was not provided.

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 awarding of contracts. 

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 (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.
 
In addition, FDA noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR 820.  These nonconformities include, but are not limited to, the following:

1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). 

For example, your firm’s corrective and preventive action (CAPA) procedure, HYWM-B-013, version B2, dated February 28, 2012, did not contain the following:

A. Identification of the actions needed to correct and prevent recurrence of nonconforming product and other quality problems;
B. Verification or validation of the CAPA to ensure that such action is effective and does not adversely affect the finished device;
C. Implementation and the recording of changes in the methods and procedures needed to correct and prevent identified quality problems;
D. Dissemination of information related to quality problems or nonconforming product to those directly responsible for assuring the quality of such product or the prevention of such problems; and
E. Submission of relevant information on identified quality problems, as well as corrective and preventive actions, to management for review.

We reviewed your firm’s response and conclude that it is not adequate.  Your firm provided an updated procedure that contains the requirements found in 21 CFR 820.100(a).  However, no evidence was submitted to indicate that a systemic corrective action (e.g., a review of historical CAPA records to ensure the CAPAs were processed per the requirements of 21 CFR 820.100) was conducted.
Evidence indicating that your firm conducted a review of its CAPA subsystem to ensure that it is now functioning within the requirements of 21 CFR 820.100 was not provided.  Lastly, evidence indicating that applicable employees were trained on the updated procedure prior to implementation, was not provided. 

2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.  Such procedures shall ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting, as required by 21 CFR 820.198(a)(3). 

For example, your firm’s complaint handling procedure, HYWM-C-06-23, version B/0, dated October 17, 2006, did not contain a requirement that a complaint be evaluated to determine whether it represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting.

We reviewed your firm’s response and conclude that it is not adequate.  Your firm stated that it would add the requirement found at 21 CFR 820.198(a)(3) into its complaint handling procedure by July 30, 2012.  However, your firm still has not provided an updated complaint handling procedure to FDA for review.  Also, evidence indicating that historical complaints were evaluated to determine if any of those complaints represented an event which was required to be reported to FDA as a MDR, was not provided.  Also, evidence indicating that applicable employees were trained on the updated compliant handling procedure prior to implementation, was not provided.  Lastly, no evidence was submitted to indicate that a systemic corrective action (e.g., a review of historical complaints records to ensure the complaints were processed per the requirements of 21 CFR 820.198) was conducted.

Your firm’s response to this letter 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 the Unique Identification Number 348538 when replying.  If you have any questions about the contents of this letter, please contact: Carl Fischer, Ph.D., at 301.796.5770.

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. 

Sincerely yours,

//S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
     Radiological Health