| Public Health Service Food and Drug Administration |
Center for Devices and Radiological Health |
Department of Health and Human ServicesDEC 16 2010
VIA UNITED PARCEL SERVICE
Ref: COR10000714
WARNING LETTER - PROGRAM DISAPPROVAL
Mr. Ronald Poe, Owner
Mega Sun, Inc.
4515 Miami St.
Saint Louis, MO 63116-1707
Dear Mr. Poe:
This letter notifies you that the United States' Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), hereby disapproves the quality control and testing program for your firm's sunlamp products including, but not limited to Models Megasun Slimline, Megasun Extreme, Megasun Crossfire and Megasun Mega V produced by Mega Sun, Inc., Saint Louis, MO. 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)).
A significant failure to comply with the requirements of the applicable performance standards was discovered during review of an establishment inspection report submitted by Ms. Kelly Sheppard and Mr. Eric Padgett, investigators of the FDA's Kansas District Office. Ms. Sheppard and Mr. Padgett's report was based on their July 27 and August 11, 2010 inspections of Mega Sun, Inc. Based on the findings listed below, CDRH finds that Mega Sun, Inc. failed to establish a quality control and testing program which ensures compliance with the applicable performance standards. Sunlamp products manufactured on or after May 7, 1980, are subject to the requirements of the Federal performance standard for sunlamp products (Title 21 CFR § 1040.20) as well as the general performance standard for electronic products (Title 21 CFR § 1010). Mega Sun, Inc. has also failed to comply with requirements for reports and record keeping (Title 21 CFR § 1002).
Specifically, your sunlamp products fail to comply with:
1. 21 CFR 1010.2(c) Certification
a. The firm's sunlamp products failed to be certified based upon a quality control and testing program in accordance with good manufacturing practices. Specifically, because your firm did not maintain any manufacturing quality control or test records for sunlamp products entered into commerce, there is no evidence that an adequate quality control and testing program exists which ensures your sunlamp products comply with the performance standard.
You are required, under 21 CFR 1003.11(b), to immediately provide a written response to FDA with the number of sunlamp products which have been produced and the number of such products that have left the place of manufacture.
Additionally, you have 15 days after you receive this letter to respond in writing using 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 (21 CFR 1003.10(b)). 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. We recommend that you submit a draft of this letter to us for review.
b. Corrective Action Plan (CAP). 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 failure to comply with the performance standard 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.
The following failures to comply with regulations regarding reports and record keeping were noted during a review of the establishment inspection report prepared by the FDA's Kansas District Office and a review of our records:
1. 21 CFR 1002.30(a)(1), 1002.30(a)(2), 1002.30(a)(4) Records to be maintained by manufacturers. The firm failed to maintain the following records:
a. Description of the quality control and testing procedures with respect to electronic product.
b. Results of tests for electronic product radiation safety including the control of unnecessary, secondary or leakage of radiation, the methods, devices, and procedures used in such tests, and the basis for selecting such methods, devices, and procedures.
c. 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.
2. 21 CFR 1002.10, 1002.11 Product reports, Supplemental reports. The firm failed to submit a product or supplemental report for each sunlamp product model or model family it manufactured and entered into commerce.
3. 21 CFR 1002.13 Annual Reports. The firm failed to submit annual reports for products it manufactured and entered into commerce.
Section 538(a) of the Act, Chapter V, Subchapter C Electronic Product Radiation Control prohibits any manufacturer from certifying or introducing into commerce sunlamp products which do not comply with the performance standard. It is also a prohibited act to fail to establish and maintain required records and failure to submit required reports. 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, to address these violations you must:
1. Submit a corrective action plan that addresses the failure to certify sunlamp products based on a quality control testing program as required by 21 CFR 1010.2(c) Certification. As indicated above you may refute the failures to comply and/or request an exemption from your responsibility to notify dealers, distributors and purchasers as described above. The regulations associated with each of these options lists the specific information required to provide a complete response.
In order for FDA to evaluate plans to correct your quality control testing program, you must provide the following items in your response:
1. A complete description of the quality control testing program, to include policies, procedures, forms and other documentation, you will use to certify your sunlamp products prior to entering those products into commerce. Include at least one set of test data and quality control records that were generated using the submitted procedures. Your quality control testing program must be documented by submission of a product or supplemental report as required by 21 CFR 1002.10 and 1002.11.
2. Documentation that your quality control testing program ensures safety and compliance of all models of sunlamp products which you intend to enter into commerce. If different models have unique features that create differences in radiation emission characteristics, how they comply with the sunlamp standard or how they are tested, your quality control testing program must account for those differences. Information on models having such unique features must be documented separately in supplemental reports as required by 21 CFR 1002.11.
3. Photographs depicting implementation of your quality control testing program at your factory. At a minimum these photographs must depict the following testing for each model of sunlamp product you currently produce:
• spectral measurements of emissions to ensure the exposure timer settings are accurate,
• calibration of each piece of test equipment (if you don't calibrate your own instruments provide a copy of outside calibration report(s)),
• use of test equipment during product compliance testing,
• placement of each required label, and
• use of the quality control form(s) used to record compliance with each of the performance standard's requirements.
In order for FDA to evaluate plans to notify purchasers and repair, replace or refund products already introduced into commerce, you must provide the following items in your response:
4. Distribution records to indicate number of sunlamp products produced and the number of such products that left the place of manufacture since you began introducing products into the US. Submit annual reports covering all models of sunlamp products entered into commerce over the last 5 years in order to bring your annual reporting up-to-date as required by 21 CFR 1002.13. Annual reports must include any communications with customers, service personnel, dealers, distributors, or regulatory agencies that reference radiation safety or radiation emissions.
5. A draft customer notification and CAP to bring products previously entered into commerce into compliance. At a minimum, your CAP should include a procedure for verifying that distributed products comply with all applicable requirements of the performance standards (21 CFR 1010 and 1040.20). The procedure must include a means of creating and maintaining a record of the tests and inspections made that confirm each product complies with all applicable requirements of the performance standard.
The CDRH will review this information and advise you whether your corrective actions are satisfactory. You may not resume introduction of sunlamp products into commerce until you establish an adequate quality testing program, complete any necessary production changes to assure compliance of all units to be entered into commerce, submit all required reports and report supplements, and receive written notification that CDRH approves your plans to correct quality testing program deficiencies. Further, it is possible that CDRH will not approve your plan or will require additional actions; therefore, we recommend that you do not pursue correction of products already entered into commerce until you receive written notification that CDRH approves your plans to bring those products into compliance.
Copies of the Federal Performance Standards, compliance guides, radiation safety lproduct report guides, and other documents related to sunlamp 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., W066-4621
Silver Spring, Maryland 20993-0002
If you have any questions regarding the content of this letter, you may contact Sharon Miller, Electronics Engineer at (301) 796-2471 or by email to SharonA.Miller@fda.hhs.gov.
Sincerely,
/s/
Lynne L. Rice
Director
Office of Communication, Education,
and Radiation Programs
Center for Devices and
Radiological Health
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