Inspections, Compliance, Enforcement, and Criminal Investigations
Professional Pad Printing Supply 22-Sep-06
Department of Health and Human Services
Public Health Service
Rockville, MD 20857
September 22, 2006
DELIVERY BY FEDERAL EXPRESS
Mr. Robert Mills
Professional Pad Printing Supply
760 8th Street, Suite #2
Vero Beach, FL
Dear Mr. Mills:
This letter is written to advise you of items of noncompliance with the DP-50Y (Toprintt TD DP-50W) Class IV Laser Marking System manufactured by Colour Print Machines Factory, Ltd., Zhu Wei Tian Village, Fenggang Town, Dongguan City, Guangdong, China 523697 and imported by your firm.
Mr. Leo Lagrotte, a representative of the Florida District Office of the US Food and Drug Administration evaluated the compliance of this machine with the requirements of the Federal regulations for radiation emitting products, including laser products contained in the US Code of Federal Regulations, Title 21, Chapter 1, Subchapter J. The evaluation was performed on July 14, 2006 at the Pad Printing Technology Co., 2803 62nd Avenue East, Bradenton, Florida 34203, the site at which the machine is installed. Attempts by Mr. Lagrotte to contact you to discuss his findings have been unsuccessful.
The FDA has determined that the DP-50Y laser marking system fails to comply with the following requirements:
1. 21 CFR 1010.2 and 1010.3: The Model DP-50Y lacks certification and identification labels on the product.
2. 21 CFR1040.10 (f)(1): The Model DP-50Y lacks adequate protective housing to prevent unnecessary access to laser radiation.
3. 21 CFR 1040.10(f)(2): The Model DP-50Y lacks safety interlocks on protective housing designed to be removed during operation or maintenance.
4. 21 CFR 1040.10(f)(3): The Model DP-50Y lacks a remote interlock connector.
5. 21 CFR 1040.10(f)(6): The Model DP-50Y lacks a properly functioning beam attenuator.
6. 21CFR 1040.10(g)(5) and (6): The product failed to have affixed an aperture label and interlocked protective housing labels.
7. 21 CFR 1040.10(h): The user information or operation manual provided with the machine was titled "Toprintt, TD DP-50W Laser Marking Machine, Operation Instruction" while the machine itself bore the marking DP-50Y. Instructions and directions for assembly, operation, and maintenance of the machine were not clearly stated or insufficient for the machine to be properly set up and operated in a safe manner. Also, the specific information required by 21 CFR 1040.10(h)(iii) to provide reproductions of product labeling and 21 CFR 1040.10(h)(iv) to provide a warning that adjustment of controls could result in hazardous radiation exposure was not included in the operation instructions.
Sections 538(a)(1) and (a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360oo(a)(1) and (a)(5)), prohibit any manufacturer from introducing into commerce or certifying laser products, which do not comply with the applicable standards. Sections 538(a)(3) and (a)(4) of the Act (21 U.S.C. 360oo(a)(3) and (a)(4) prohibit any manufacturer from failing or refusing to establish and maintain required records or to submit required reports. Failure to respond to this letter may be considered to be a violation of Section 538(a)(4) of the Act.
The Food and Drug Administration (FDA) is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and 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 $1,000 per violation, up to a maximum penalty of $300,000.
Under section 531(3) of the Act (21 U.S.C. 360(h)(3)), a manufacturer includes any person engaged in the business of manufacturing, assembling or importing electronic products. Thus, in cases where a foreign manufacturer fails to respond, action may be taken against a person who imports the electronic products.
You are required under 21 CFR 100).11 (b) to respond in writing 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. In addition, if the product distribution is confined to specific geographical areas of the United States, please specify those areas. Your response should be provided no later than 15 days from receipt of this letter.
l. Refutation - Under 21 CFR 1003.11 (a)(3), you may submit your views and evidence to establish that the alleged failures 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 21 CFR 1003.10(b).If exempted from such notification, you are not required to correct the violative products (21 CFR 1004.1(a)). Under 21 CFR 1003.30(b), your request must include the information required by 21 CFR 1003.20 and set forth in detail the grounds upon which such exemption is sought.
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, as specified in 21 CFR 1003.10(b), of the violative products; and (b) submit, as required by 21 CFR 1004.1(b), 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 plan must expeditiously correct the noncompliance(s) and must be approved by FDA 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 should 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 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.
In addition, the following failures to comply with regulations regarding reports and record keeping were observed:
1. 21 CFR 1002.10: Colour Print Machines Factory, Ltd. failed to submit product reports on any of its models of laser products, including the model evaluated.
2. 21 CFR 1002.13: Colour Print Machines Factory, Ltd. failed to submit annual reports on its laser products.
You are responsible for complying with all applicable statutory and regulatory requirements before these products are introduced, or delivered for introduction, into commerce, or imported into the United States. Such requirements include the completion of any production changes required by 21 CFR 1004.1 under a plan approved by FDA to assure compliance of future units, and the submission of any required reports. Your response should be sent to: Chief, Electronic Products Branch (HFZ-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. If you have further questions on these requirements, please contact Jerome Dennis of the Electronic Products Branch at (240) 276-3332.
Lynne L. Rice
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health