| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
SEP 23 2010
VIA UNITED PARCEL SERVICE
Ref: COR10000404
WARNING LETTER -- PROGRAM DISAPPROVAL
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 disapproves the quality control and testing program for all laser products including, but not limited to Models IB-1284 and GT-1000 produced by Mundt & Associates, Inc., Scottsdale, AZ. This action is taken 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)].
This disapproval means that your firm is prohibited by Sections 534(h) and 538(a) of the Act from:
1. Certifying the electronic products manufactured under the disapproved testing program (§ 538(a)(5)(B)),
2. Introducing, delivering for introduction, or importing into U.S. commerce any product which does not comply with the applicable standard (§ 538(a)(1)), and
3. Introducing or importing into U.S. commerce any product which does not have a certification as required by section 534(h) and (§ 538(a)(5)(A)).
Several items of noncompliance were discovered after reviewing our records containing your firm's product and annual reports and an establishment inspection report submitted by Mr. Francis Eng, investigator and electro-optics specialist of the Food and Drug Administration, Pacific Regional Field Office. Mr. Eng's report was based on his March 30, 2010 inspection of Mundt & Associates, Inc., which focused on the Model IB-1284 Laser Interconnect Bonder (IB-1284), Model GT-1000, and the supporting quality test program. Based on the findings listed below, CDRH finds that Mundt & Associates, Inc. has failed to establish a quality test program which ensures compliance with the FDA regulations.
Specifically, the items of noncompliance include the following:
1. 21 CFR 1010.2(c) Certification.
a. The firm's laser products failed to be certified based upon a testing program in accordance with good manufacturing practices. Specifically, your firm did not maintain any manufacturing quality test records for laser products entered into US commerce.
b. The firm failed to properly classify its "Hayward" Filter Cutting Laser System (FDA Accession number (b)(4)). The system incorporates a Class IV laser which is enclosed within a room using a barrier with clear viewing ports. The product report states the laser system has a cover over the entire machine, yet there is access to reflected radiation from an open beam. The report states that the barrier's clear viewing ports will attenuate all laser radiation emitted from the laser, yet properly rated eye protection is still required. Attachment D also states that the enclosure does not inhibit beam to Class I standards.
2. 21 CFR 1002.30(a)(1-4) Records to be maintained by manufacturers. The firm failed to maintain the following records:
a. Description of the quality control procedures with respect to electronic product radiation safety.
b. Results of tests for electronic product radiation safety including the control of unnecessary, secondary or the leakage of electronic product radiation, the methods, devices, and procedures used in such tests, and the basis for selecting such methods, devices, and procedures.
c. Results of tests for durability and stability of the product, and the basis for selecting these tests.
d. Copies of communications between the manufacturer and dealers, distributors, and purchasers concerning radiation safety including complaints, investigations, instructions, or explanations affecting the use, repair, adjustment, maintenance, or testing of the listed products.
3. 21 CFR 1002.10 Product reports. The firm failed to submit a product report for each product it manufactured and entered into US commerce, and those submitted reports do not adequately identify which listed product is being reported. CDRH records contain product reports for 6 Mundt laser products. It appears that your firm has only submitted 6 out of 19 laser products listed on your firm's annual reports dating back to January 2005. One product report (Accession number (b)(4))identifies a purchased laser product from another company, but does not identify the model of the resulting laser product manufactured by your firm after incorporation of the purchased laser. Another product report (Accession number (b)(4) does not identify the model number provided in the annual report with the name given in the product report.
4. 21 CFR 1040.10(h)(2)(i) Informational requirements - Purchasing and servicing information. The firm's promotional brochures and internet site lacks a legible reproduction of the class designation and warning labels for Models IB-1284 and GT1000.
5. 21 CFR 1040.10(h)(2)(ii) Informational requirements - Purchasing and servicing information.
a. The firm's operator manual for the Model IB-1284 Laser Interconnect Bonder lacks service information.
b. All of the firm's product reports lack adequate service and maintenance information. There is reliance on the component laser operator manuals which do not include adequate radiation safety information for service and maintenance functions for the finished laser product. The service and maintenance information found in the firm's product reports includes information about safety interlocks, but does not provide information on safety procedures for the listed functions such as realigning mirrors and adjusting the final focus when the laser beam would be operational.
You are required, under 21 CFR 1003.11(b), to immediately provide a written response to FDA with the number of laser products which have been produced and the number of such products that have left the place of manufacture. In addition, if the product distribution were confined to specific geographical areas of the United States, please specify those areas.
We request that you provide such a response no later than 15 days after receipt of this letter with one of the options listed below:
1. Refutation. Under 21 CFR 1003.11(a)(3), you may submit your views and evidence to establish that the alleged failures to comply do not exist.
2. Exemption Request. Under 21 CFR 1003.30(a), you may request an exemption from user and dealer/distributor notification requirements in Under 21 CFR 1003.10(b). You must respond within 15 days from receipt of this letter to apply for such an exemption. If exempted from such notification, you are not required to correct the violative products (under 21 CFR 1004.1(a)). Your request must include the grounds upon which such exemption is requested (see 21 CFR 1003.30 and 1003.31) and the information required under 21 CFR 1003.20.
3. Purchaser Notification and Corrective Action. If you neither refute the noncompliance nor request an exemption, then you must: (a) notify purchasers and dealers/distributors of the violative products as specified in 21 CFR 1003.10(b), and (b) submit a written corrective action plan (CAP) for approval showing how you will fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the violative products.
a. Notification Letter. Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy of the notification letter(s) sent to purchasers and dealers must also be sent to the FDA. It is recommended that you submit a draft of this letter to us for review.
b. Corrective Action Plan. Instructions for preparation of a CAP may be found in 21 CFR 1004.2, 1004.3, or 1004.4. Such a plan must expeditiously correct the non-compliances and must be approved as set out in 21 CFR 1004.6.
If you request additional time to prepare your refutation, notification, CAP, or evidence to support a requested exemption, you must provide the reasons for any delays and a reasonable target date for the full submission of your response. Be aware that if an acceptable CAP cannot be prepared promptly, you may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11 (c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.
Be advised that failure to respond to this letter may be considered to be a violation of section 538(a)(4) of the Act, 21 U.S.C. § 360oo(a)(4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. § 360pp.
Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.
In summary, unless you decide to refute these allegations or request an exemption from dealer/distributors notification requirements, you must:
1. Provide a list of all laser models manufactured and sold since 1995.
2. Submit a supplemental report describing the quality control procedures you will use common to all production as found in 21 CFR 1002.30(a), with respect to electronic product radiation safety information. Model-specific quality control procedures must be submitted as separate supplemental reports, referencing the appropriate product report Accession number ((b)(4), (b)(4), (b)(4), (b)(4), (b)(4) and(b)(4)). Additionally, submit photographs depicting quality control program procedures which must include, but not be limited to power measurements of the laser, radiation leak tests, your firm's test equipment, tests of interlocks, and placement of labels. This must be done so CDRH can determine that Mundt & Associates, Inc. is in compliance with the Act, that the subject products comply with the performance standard, and that the testing program is in accord with good manufacturing practices.
3. Submit product reports for all laser products entered into US commerce including those listed in your firm's annual reports with Accession numbers (b)(4) and (b)(4) for which your firm has not already submitted product reports. Products must be identified by a name provided by your firm, not by the model name of a component or an uncertified laser product your firm purchased and modified. If model families exist for your products, list all laser products which belong to a model family for current and past production, and include this information in the supplemental reports mentioned in Item 2.
Be advised that supplemental reports must also be submitted for those laser products within a model family which have changes in radiation emissions, affect the manner of compliance with a standard, or affect manner of testing for radiation safety from the base model.
4. Properly classify the "Hayward" Filter Cutting Laser System (Accession number (b)(4))and clarify how the operator will not be exposed to any radiation in excess of Class I limits. Include these corrections in a supplemental report referencing the Accession number.
5. For Models IB-1284 and GT-1000, submit copies of excerpts from catalogs, brochures, and specification sheets containing legible reproductions of the class designation and warning labels to be affixed.
6. Submit a CAP which includes a procedure for performing the quality control procedures on all products sold to assure they comply with regulations found in 21 CFR 1010, 1040.10, and 1040.11. The CAP should also address both Mr. Eng's informational requirement observations as well as those deficiencies identified in your firm's product reports.
In addition to being included in the CAP, the informational requirement corrections must be included in the previously mentioned supplemental reports for the applicable product reports. Any discoveries of defect or failure to comply discovered during the execution of the CAP must be reported to CDRH immediately as per 21 CFR 1003.10.
7. Notify all dealers, distributors, and purchasers of your firm's failure to comply with FDA regulations for all of your firm's laser products. In accordance with 21 CFR 1003.21 Notification by the manufacturer to affected persons, your firm must also provide CDRH with copies of communications sent to purchasers, dealers or distributors in accordance with 21 CFR 1003.22.
The CDRH will advise you whether your CAP and requested information are satisfactory.
When you have completed any necessary production changes to assure compliance of future units, CDRH determines that you have established an adequate quality testing program, and you have submitted the required reports and report supplements, you may resume introduction of these products into commerce. Note, you must correct the non-compliances with an approved CAP for all sold products.
Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to laser products are available on FDA's web site at:
http://www.fda.gov/Radiation-EmittingProducts/default.htm.
Your response should be sent to:
Chief, 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., WO66-4621
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.
Sincerely yours,
/S/
Lynne L. Rice
Director
Office of Communication, Education,
and Radiation Programs
Center for Devices and
Radiological Health
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