Inspections, Compliance, Enforcement, and Criminal Investigations
Sunder Biomedical Tech Co. Response Letter
July, 04, 2005
Paul Tilton, Chief, OB/GYN
Gastroenterology and Urology Devices Branch
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Division of Enforcement A
2098 Gaither Road
Rockville, Maryland 20850 USA
Dear Mr. Tilton:
This letter is to response warning letter dated April 23, 2004; we received from Timothy A. Ulatowski.
The contents of data are the corrective actions and revised steps that have been implemented . We made the greatest effort to resolve those violations that observations cited.
1. Response to warning letter No.1 and 483 observation No.1
The protocol and result reports of clean room validation and IQ/OQ/PQ are supplemented. In addition, the purpose of these remedies is to ensure compliance
with 21 CFR 820 .75(a), And our clean room can be maintained its function and meet requirement of ISO 14644-1.
2. Response to warning letter No.2 and 483 observation No.3
We revised the current procedures "Design Control Management [redacted] including the design control, change and other relatives to meet as suitable as the regulations of 21 CFR Part 820.30). The future projects will be followed these revised procedures and establish same procedures, such as user needs, development
planning, design input, design output, verification, validation, design transfer and design history.
3. Response to 483 observation No.2
We revised the procedure of "Internal quality audit" [redacted] specify audit plan and adding audit checklist to assure have audited all elements in the quality system. The procedure of internal quality audit includes planning an audit schedule, assignment of responsibilities, notifying internal audit activity, releasing internal audit activity, releasing internal audit deficiency record, follow up the corrective action and management review of results storing the record.
4. Response to 483 observation No. 4
From now on, while a complaint issued, the receiving people will do the investigation and evaluation for any possible conditions such the relative devices/instrument used, patient or [redacted] operation to verify the possible real defects caused. Further, if the reason caused is on our side, then a corrective action, moreover, the protective solution should be adopted according to our internal SOP and all relative regulations.
5. Response to 483 observation No.5
We revised the design change procedure by adding evaluation, investigation and review process. However, all charges should be compliance with the current regulation and do the correct judgment in the evaluation process.
We hope the above responses represent a clear portrayal of actions taken and of the new policies that have been implemented to comply with regulations and prevent such occurrences in the future. We remain committed to patient safety and to the highest standards of biomedical manufacture.
Chairman, Sunder Biomedical Tech Co., Ltd..