• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Beam of Light Technologies, Inc. 27-Jul-05

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

Public Health Service
Food and Drug Administration

 

Rockville MD 20857


JUL 27 2005

WARNING LETTER

Ref : I1-1975

Mr. John M. Mueller, President/Owner
Beam-of-Light Technologies, Inc.
10117 SE Sunnyside Road
Ste. #F, MB 324
Clackamas, Oregon 97015

Dear Mr. Mueller:

This letter is to notify you that the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) has determined that laser products produced by your firm Beam-of-Light Technologies, Inc. (aka Z-Bolt) fail to comply with applicable Federal requirements. The laser products manufactured by your firm must comply with general requirements contained in Title 21 of the Code of Federal Regulations (CFR), Parts 1000 - 1050, and specifically the U.S. Performance Standards for Light Emitting Products contained in 21 CFR Sections 1040.10 and 1043.11.

The following observations were noted during an inspection conducted at your facility on February 7, 2005 by Mr. Gary Zaharek, Electro-Optics Specialist, San Francisco District Office, U.S. Food and Drug Administration

1. 21 CFR Part 1002.10, Product reports. Failed to submit product reports in accordance with the requirements of this section. It was observed that all laser products produced or modified by your firm, including models DPSS-60 (Leadlight Model GTML3C1), MOD-1, MOD-2 and the BTG-2S laser pointer were not reported to FDA prior to distribution into the U.S. Laser products must be reported to FDA prior to introduction into U.S. commerce. Modification of a certified laser product, which results in a change in the performance features and/or labeling requirements for that product, is considered an act of manufacture. This requires the firm making the changes to recertify the modified model(s) and report the product(s) to CDRH as required by this section.

2. 21 CFR Part 1002.30, Manufacturers' records. Failed to establish and maintain records as required by this section. It was observed that no manufacturing records were maintained by your firm.

3. 21 CER 1010.2, Certification. Failed to base certification of products upon a test or testing program which ensures compliance with the applicable U.S. Performance Standards for Light Emitting Products. it was observed during the inspection that no manufacturing records. including test records, were maintained by your firm. Operations conducted at your firm include distribution of laser products and modification of laser products resulting in a change in the performance features and/or labeling requirements for those products. Modification of products requires you recertify the modified model(s) and report the product(s) to CDRH.

4. Examination of the model DPSS-60 (GLM 3C1), a Class IIlb laser product revealed the following:

a. The product failed to have affixed a certification label as required by 21 CFR 1010.2;

b. The product failed to have a manufacturer's identification label as required by 21 CFR 1010.3;

c. The product failed to incorporate a beam attenuator as required by 21 CFR 1040.10(f)(6); and

d. The user instructions which accompanied the product failed to include a reproduction of and information indicating the location of each required warning label as specified at 21 CFR 1040.10(h) (iii). The user instructions also failed to include the required statement "Caution-Use of controls. . . ." as required by 21 CFR 1040.10(h)(iv).

We acknowledge receipt of ,your letter dated March 3, 2005 to Mr. Zaharek in response to his inspectional observations, describing the action you have taken to address these matters:

1) You have stated that you will no longer sell the DPSS-60 or DPSS-100,

2) You have stated that you have discontinued and will no longer sell the MOD-1 and MOD-2,

We thank you for this information. However, we note that the DPSS-60, DPSS-100, and other Class IIIb models continue to be listed for sale on your website at www.z-bolt.com.

Please be advised that Section 538(a) of the Federal Food, Drug, and Cosmetic Act (the Act), Chapter V, Subchapter C (formerly the Radiation Control for Health and Safety Act of 1968) prohibits any manufacturer from introducing into commerce laser products which do not comply with certification requirements or any other applicable performance standard prescribed under Section 534 of the Act. This section also prohibits any manufacturer from failing to establish and maintain required records or to submit required reports.

The Food and Drug Administration (FDA) is prepared to invoke regulatory actions if you fail to comply with the requirements described above. These actions may include an injunction and/or imposition of civil penalties as provided for in Section 539 of the Act. Persons failing to correct violations and/or who continue to violate the Act are subject to civil penalties of up to $1,000 per violation with a maximum penalty of $300,000.

You must respond in writing within 15 working days of receipt of this letter to one of the options listed below. In your response, you must also provide the number of the referenced products which have been produced and the number of such products that have left the place of manufacture. 21 CFR 1003.11(b). In addition, if the product distribution was confined to specific geographical areas of the United States, please specify those areas.

1. Refutation - You may submit your views and evidence in accordance with 21 CFR 1003.11{a}(3) to establish that the alleged failures to comply do not exist. Should you choose to refute the allegation of noncompliance, you will have an opportunity to request a hearing under 21 CFR Part 16.

2. Exemption Request - You may request an exemption from the user and dealer/distributor notification requirements found in 21 CFR 1003.10(b) and from the obligation to correct the violative products. Your request must include the grounds upon which such exemption is requested (see 21 CFR 1003.30 and 1003.31).

3. Purchaser Notification and Corrective Action - If you neither refute the noncompliance(s) nor request an exemption from notification, 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) showing how you will fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the violative products at no charge to the user.

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 noncompliance (s) and must be approved by FDA. (see 21 CFR 1004.6).

If you request additional time to prepare your refutation, purchaser notification, CAP, or evidence to support a request for exemption from notification requirements, 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 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.

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/cdrh/comp/eprc.html

Your response should be sent to: Chief, Electronic Products Branch (HEZ-240), Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and. Radiation Programs, Center for Devices and Radiological Health, 1350 Piccard Drive, Rockville, Maryland 20850. You are also requested to send a copy of your response to: Director, Compliance Branch, Seattle District Office, Food and Drug Administration, 22201 Drive S.E., P.O. Box 3012, Bothell, WA 98041. If you have further questions on these requirements, please contact Sean Boyd or Frank Mackison of the Electronic Products Branch at (240) 276-0326.

Sincerely yours,

/S/

Lynne L. Rice
Director
Office of Communication, Education,
and Radiation Programs
Center for Devices and
Radiological Health