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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Rossmax International Ltd 27-May-08

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

Public Health Service
Food and Drug Administration

 

Center for Devices and
Radiological Health
9200 Corporate Blvd
Rockville, MD 20850


May 27, 2008

VIA FEDERAL EXPRESS

Mr. Michael Yeh
President/CEO
Rossmax International Ltd.
12 F., No. 189
Kang Chien Road
Taipei, Taiwan
Republic of China

Dear Mr. Yeh:

On March 28, 2008, the Food and Drug Administration (FDA) issued a Warning Letter to Rossmax Internation Ltd. stemming from two inspections of your facilities that occurred October 22, 2007, through November 1, 2007. You provided a written response dated April 18, 2008, to the FDA Warning Letter that included revised procedures and narrative responses to the Warning Letter deficiencies. Several issues from the Warning Letter have not been adequately addressed. Therefore, please address the following deficiencies:

1. You provided the revised procedure [redacted] to satisfy the requirements of 21 CFR 820.75, Process Validation. This is not adequate to describe the validated processes at your firm. Please provide a new or revised procedure that includes the following for the validated processes:

a. Any validations of software used as part of the production or quality system;

b. Objective and measurable acceptance criteria;

c. Appropriate statistical methods for data collection and analysis that are used.

2. You provided Corrective and Preventive Action (CAPA) investigation reports [redacted] as required by your procedure, [redacted]. These CAPA investigation reports are not adequate in that they contain only a root cause investigation and do not include any corrective or preventive actions. Please provide new or revised CAPA investigation reports that include the corrective and preventive actions that were taken to prevent the failures from recurring.

3. You provided the test report for the heat tunnel alarm system in Appendix 8 of your response. This is not adequate to ensure that the alarm is suitable for its intended use. Please provide the test results that are accompanied by valid statistical methods for data collection and an analysis of this data to show that the alarm can be used reliably for its intended use.

4. You provided a written summary of the Purchasing Control procedures used at Rossmax. This is not adequate to describe the purchasing controls used at your firm. To satisfy the requirements of 21 CFR 820.50, please provide the following:

a. The written agreements or procedures between Rossmax and any of its US customers, agents, or distributors that defines the responsibilities of the parties in regard to labeling or supplier agreements.

b. The written agreement or procedure that ensures the review and approval of all activities required in the Device Master Record (DMR) and ensures that the Device History Record demonstrates the device was manufactured in accordance with the DMR.

c. The written agreement or procedures that explain the roles of Rossmax and HoMedics with regard to lot release and distribution tasks. For example, the Warning Letter response, dated April 18, 2008, states that Rossmax is responsible for inspection and release of finished devices. However, it was found at inspection that HoMedics performs these tasks. Please clarify which firm is responsible for these tasks.

In addition, if the procedures followed at Rossmax are part of an agreement to use HoMedics' Quality Manual, please provide documentation of this agreement as well as documentation of the procedures in the Quality Manual that are used at Rossmax.

5. You provided a narrative of your design control procedure to explain how design and specification changes are made at your firm. This is not adequate to describe all aspects of design control. Please provide the following to fully satisfy the requirements as listed and described in 21 CFR 820.30, Design Controls:

a. Design and development planning;
b. Design Input;
c. Design Output ;
d. Design Review;
e. Design Verification;
f. Design Validation;
g. Design Transfer;
h. Design Changes;
i. Design History File.

6. You provided a summary of your intention to revise the document controls procedure to include the use of stamps for document review and approval. This is not adequate to satisfy the requirements of 21 CFR 820.40, Document Controls. Please provide the procedure that addresses the use of ink stamps for document review and approval.

Please respond in writing within 30 days of receipt of this letter. If you require additional time to complete your response please contact either Ms. Jennifer Medicus or Ms. Amy Skrzypchak about your need for more time to respond. Your written response should be sent to:

Jennifer Medicus
Acting Chief
Orthopedic, Physical Medicine and Anesthesiology Devices Branch/HFZ-343
Office of Compliance
Center for Devices and Radiological Health
2094 Gaither Road
Rockville, Maryland 20850

If you have any questions concerning this matter, you may contact Ms. Amy Skrzypchak at 240-276-0274 or at amy.skrzpchak@fda.hhs.gov.

Sincerely yours,

/S/

Gladys Rodriguez
Director
Division of Enforcement B
Office of Compliance
Center for Devices and
Radiological Health