Inspections, Compliance, Enforcement, and Criminal Investigations
Mundt & Associates Inc - Close Out Letter 12/15/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
DEC 15 2010
VIA UNITED PARCEL SERVICE
Mr. Ronald Mundt, President
Mundt & Associates, Inc.
14682 N. 74th Street, Ste. 150
Scottsdale, AZ 85260
Dear Mr. Mundt:
This letter notifies you that the United States (U.S.) Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) hereby reinstates the quality control and testing program for all laser products produced by Mundt & Associates, Inc., Scottsdale, AZ. Your firm may resume entering laser products into US commerce.
In its September 23, 2010 letter, CDRH notified you that your firm's quality control and testing program for all laser products was disapproved under the authority of the U.S. Federal Food, Drug, and Cosmetic Act (the Act), Chapter V, Subchapter C, Electronic Product Radiation Control, Section 534(h) [U.S.C. 360kk(h)]. The program disapproval was based on several items of noncompliance discovered after reviewing our records containing your firm's product and annual reports and a June 22, 2010 Establishment Inspection Report (EIR) submitted by Mr. Francis Eng, investigator and electro-optics specialist with the Food and Drug Administration, Pacific Regional Field Office.
In the September 23, 2010 letter CDRH stated that after you established an adequate quality testing program, and submitted the required reports and report supplements, you may resume introduction of your firm's products into US commerce. Following these changes, future units will be in compliance with 21 CFR Subchapter J.
On October 19, 2010 you submitted a document listing all laser models manufactured and sold since 1995, including four models which were out of service and inoperable. On November 7, 2010 your firm submitted the following documents:
1. Laser system quality control test procedure for your firm's IEC Class 1 and Class 4 laser products
2. Laser test report for a model YLR-150/1500-QCW-AC laser
3. Quality checklist used for your firm's IEC Class I and Class 4 laser products
4. Draft notification letter to affected persons
5. Draft corrective action plan (CAP)
6. Product report for a model GP-1812 laser welder with attachments.
On November 17, 2010 you submitted a revised notification letter to affected persons and a CAP that consisted of the following:
1. Implementing a product certification program that is in accordance with CFR 1040.10 and good manufacturing practice and will be the standard protocol for all new machines.
2. Implementing a records maintenance program in accordance with CFR 1002.13 and 1002.30.
3. Submitting required notifications to CDRH and to affected persons.
4. Correcting informational requirements in accordance with 1040.10(h)2)(ii) and update your firm's website to reflect those corrections. Discontinue use of old printed brochures.
5. Updating all FDA product report submittals to conform to the approved quality test program.
6. Completing Numbers 1-5 on or before April 1, 2011.
CDRH approved your revised draft notification letter to affected persons and CAP as per instructions in a November 3, 2010 electronic mail message, and allowed you to proceed with the implementation of the CAP under the following conditions:
1. Notification of all dealers and purchasers is made, and this office is to be included in the notification.
2. Corrections to informational requirements such as those described in your GP-1812 laser welder product report are distributed to purchasers at no cost to them. Corrections include providing purchasing, servicing and radiation safety information in all operator manuals as well as danger logos in promotional brochures including those on the firm's internet site.
3. Completion of the CAP by May 1, 2011.
4. Fully compliant laser products produced in the future.
On December 2, 2010 you submitted copies of 13 notification letters to affected persons, and on December 8, 2010 you submitted the following documents:
1. Supplemental report for the model GP-182 laser welder.
2. GP-1812 laser welder quality test procedure.
3. Product report for a model IB-1284 laser welder with attachments.
4. Supplemental report for the model IB-1284 laser welder.
5. IB-1284 laser welder quality test procedure
6. Product report for model SG-1805 general purpose laser process system with attachments.
7. SG-1805 general purpose laser process system quality test procedure.
6. Status report of all products ever produced.
You are advised that it is FDA policy to report the facts surrounding all defect and noncompliance cases subject to Section 535 of Subchapter C - Electronic Product Radiation Control of Chapter V of the Federal Food, Drug, and Cosmetic Act. This report is made available to the public in the FDA Enforcement Report.
All copies of any remaining notification letters and other correspondence should be sent to:
CDR Patrick J. Hintz, USPHS Health Promotion Officer, Electronic Products Branch
Division of Mammography Quality and Radiation Programs
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
10903 New Hampshire Ave., W066-4621
Silver Spring, Maryland 20993-0002
If you have any questions regarding the content of this letter, you may contact CDR Patrick J. Hintz, Health Promotion Officer at (301) 796-6927 or by internet electronic mail at Patrick.Hintz@fda.hhs.gov.
Helen J. Barr, MD
Division of Mammography Quality
and Radiation Programs
Office of Communication, Education,
and Radiation Programs
Center for Devices and