Virtual Sun, LLC 10/9/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
October 9, 2013
WARNING LETTER NO. 2014-NOL-01
UNITED PARCEL SERVICE
Delivery Signature Requested
Ricky R. Pierce, President
Virtual Sun, LLC
28035 Highway 31 North
Jemison, Alabama 35085-7883
Dear Mr. Pierce:
During an inspection of your firm, located at 28035 Highway 31 North, Jemison, Alabama, on June 19 and July 17, 2013, an investigator from the United States Food and Drug Administration (FDA) determined your firm manufactures tanning beds. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code (USC) 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). We received your response letter, with enclosures, dated July 31, 2013, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483), issued to you on July 17, 2013. We address the responses below, in relation to each of the noted violations. The violations include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures for implementing corrective and preventive action (CAPA) including requirements for analyzing sources of quality data, investigating the cause of nonconformities from sources other than product returns, requirements for identifying required actions, or requirements for verifying the effectiveness of actions, as required by 21 CFR 820.100(a).
You explain in your written response you intend to establish written procedures for identifying and acknowledging any failures of your products. You also explain you are establishing procedures for recording, implementing, reviewing, and verifying that corrective actions are documented and implemented. You have not provided the procedures.
2. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
You explain in your written response you will establish procedures to describing how will handle complaints. You have not provided the procedures.
3. Failure to establish procedures for acceptance for incoming product, as required by 21 CFR 820.80(b). Specifically, there is no documentation or description of tests and/or checks made on incoming parts, including filters, reflectors, timers, ballasts, and lamps, prior to their acceptance to ensure the final product complies with the performance standard for sunlamp products.
You explain in your written response you will thoroughly document additional in-house testing and evaluation procedures including establishing protocols for ensuring that compliance is consistent. You have not provided the procedure.
4. Failure to establish procedures for in-process and final acceptance activities, such as inspection, test, or other verification activities to ensure your tanning beds conform to specified requirements, as required by 21 CFR 820.80(a).
5. Failure to establish or maintain a device master file, as required by 21 CFR 820.181. Specifically, you failed to maintain a device master file for the SunMaster Shadow tanning bed models.
You explain in your written response you intend to consolidate existing information into Device Master Records (DMR). You explain further that you will include device specifications, production procedures, quality assurance methods and procedures, package and labeling specifications, and any other applicable procedures. We agree with this corrective action.
6. Failure to maintain device history records, as required by 21 CFR 820.184. Specifically, you failed to document and maintain device history records for your tanning beds including the dates of manufacture, the quantity manufactured, the quantity released for distribution, the primary identification label, any device identification and control numbers, and the acceptance records which demonstrate the device is manufactured in accordance with the device master file.
You explain in your written response you will begin producing acceptance records in accordance with the DMR once you have fully compiled and validated the required DMR. We agree with your stated corrective action.
7. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a). Specifically, your firm has not established written procedures to ensure that your (b)(4) tester, used to conduct high voltage testing on your tanning beds, is routinely calibrated and inspected annually. The tester was observed to have been last calibrated on January 12, 2009.
You explain in your written response you will either discontinue using the (b)(4) tester or calibrate the (b)(4) tester.
8. Failure to establish procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm failed to establish and implement purchasing control procedures to ensure that supplies and contract manufacturing services meet your established specifications. In addition, there is no clear agreement with your suppliers and contractors that your firm will be notified prior to changes in the product or service so you may determine whether the changes may affect the quality of your finished device.
You explain in your written response you will develop procedures to ensure conformance of material specifications. In addition, you state you will maintain agreements with suppliers of materials and/or services attesting to their commitment to keep us apprised of any changes to their product design, specifications or performance so that you may determine if any such changes could affect the performance and reliability safety of your product. You have not provided the procedures.
9. Failure to document employee training for an employee manufacturing and certifying your tanning beds, as required by 21 CFR 820.25(b). Specifically, you failed to provide any documentation to demonstrate the employee has the necessary education, background, training, and experience to perform the duties that he’s responsible to perform.
You explain in your written response you will develop a personnel training program covering all aspects of production, safety and quality assurance. In addition, you will establish procedures for ensuring that training is adequate, thorough and current for employees. You have not provided the procedures.
Our inspection also revealed your devices are misbranded under Section 502(t)(2) of the Act, [21 USC 352(t)(2)], because your firm failed or refused to furnish material or information required by or Under Section 519 of the Act, [21 USC 360i], and 21 CFR 803 - Medical Device Reporting (MDR) regulation. Specifically, you failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
You explain in your written response you intend to develop, implement, and maintain written procedures for MDR and implement a schedule of internal self-auditing to ensure the procedures are understood and routinely implemented. You have not provided the procedures.
You should take prompt action to correct the violations addressed in this letter for which you have not already provided an adequate response. 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/or civil money penalties. Also, federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations for which you have not already provided an adequate response, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective action you have taken, such as your revised procedures. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Mr. Mark W. Rivero, Compliance Officer at the above address. If you have any questions regarding the content of this letter please contact Mr. Rivero at (504) 832-1290, extension 1103.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483, issued at the closeout of the inspection, may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Patricia K. Schafer
New Orleans District