Inspections, Compliance, Enforcement, and Criminal Investigations
Mega Sun Inc 3/22/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Kansas City District|
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
March 22, 2013
RETURN RECEIPT REQUESTED
Ronald S. Poe, Owner
Mega Sun Inc.
4515 Miami Street
St. Louis, MO 63116
Dear Mr. Poe:
On February 28 through March 6, 2013, a United States Food and Drug Administration (FDA) investigator conducted an inspection of your facility located at 4515 Miami Street in St. Louis, Missouri 63116. During this inspection, our investigators documented significant deviations from the current good manufacturing practice regulations for medical devices, Title 21 Code of Federal Regulations, Part 820 (21 CFR Part 820). Your products are considered to be medical devices within the meaning of Section 201 (h) [21 U.S.C. 321(h)] of the Food, Drug, and Cosmetic Act (the Act) and the deviations from current good manufacturing practice regulations observed during the inspection render medical devices manufactured at your facility adulterated within the meaning of Section 501(h) [21 U.S.C. 351(h)] of the Act. You can find the Act and its implementing regulations from links on FDA's homepage at www.fda.gov.
Section 501(h) of the Act states "A device shall be deemed adulterated - If it is a device and the methods used in, or the facilities used for, its manufacture, packaging, storage or installation are not in conformity with applicable requirements under section 520(f)(1) or an applicable condition prescribed by an order under 520(f)(2)". Specifically, your deviations from current good manufacturing practice regulations include, but are not limited to, the following:
1. Failure to have management with executive responsibility ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20(a). Specifically, your firm has failed to establish and implement a quality policy and procedures that ensure your firm's Slim Line, Mega Max, Mega V, and Crossfire/Extreme model tanning beds are produced according to established specifications. You have failed to provide any training on a quality policy and procedures to your employees. The result of this failure to provide training on and implement a quality policy at all levels of the organization was evident from a review of device history records dating back to May 5, 2012 which revealed a consistent failure to record all information, signatures, and dates required to be a part of the quality control checklists.
2. Failure to adequately establish procedures for finished device acceptance, as required by 21 CFR 820.80(d). Specifically, your firm has failed to adequately establish procedures for finished device acceptance criteria in a manner which ensures that approved and released Slim Line, Mega Max, Mega V, and Crossfire/Extreme model tanning beds meet your firm's established criteria, For example, your specification charts for several models including the Mega Max model list a target "amp draw" which is outside of the listed acceptable range.
3. Failure to adequately maintain a device history record, as required by 21 CFR 820,184, Specifically, a review of device history records dating back to May 5, 2012 revealed a consistent failure to record all required information, signatures, and dates within the quality control checklists which are a part of your device history record, For example, your firm's table of acceptable readings for (b)(4) lists acceptable values for both the bed and canopy, while some of your device history records list only one test result, or even simply have a checkmark with no value for either test result.
4. Failure to conduct quality audits, as required by 21 CFR 820,22, Specifically, your firm's procedure MS 820.22 "Quality Audits" established December 15, 2011, requires a "complete and comprehensive audit of the quality system .. , at least (b)(4) per calendar year". To date, no quality audits reviewing the effectiveness of the quality system used to monitor the quality of Slim Line, Mega Max. Mega V, and Crossfire/Extreme model tanning beds have been conducted at your facility.
5. Failure to establish procedures for training and identifying training needs, as required by 21 CFR 820.25(b). Specifically, your firm could not produce documentation of training conducted to educate employees on your firm's newly established procedures, including the procedure for completing a device history record.
6. Failure to establish procedures for corrective and preventative actions as required by 21 CFR 820.100(a). Specifically, you have no procedures in place to evaluate problematic issues which may arise and there is no mechanism in place to prevent such issues from recurring. Your firm could not produce any documentation of procedures for corrective and preventive actions for quality issues that relate to the manufacturing, sale, and distribution of Slim Line, Mega Max, Mega V, and Crossfire/Extreme model tanning beds.
7. Failure to establish written procedures for management review, as required by 21 CFR 820.20(c). Specifically, your firm has failed to establish Management Review procedures to ensure all quality issues related to the production of Slim Line, Mega Max, Mega V, and Crossfire/Extreme model tanning beds are discussed during required management review meetings.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent to: Amy E. Devine, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Drive, Lenexa, Kansas 66214-1524. Refer to KAN2013-07 when replying. If you have any questions about the contents of this letter, please contact Compliance Officer Devine at 913-495-5147.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
John W. Thorsky
Kansas City District