WARNING LETTER
ProSun International, LLC MARCS-CMS 539273 —
- Delivery Method:
- UPS
- Recipient:
-
Recipient NameTom Henkemans
- ProSun International, LLC
2442 23rd St N
Saint Petersburg, FL 33713-4018
United States
- Issuing Office:
- Florida District Office
United States
Office of Medical Device and Radiological Health Operations (OMDRHO) | |
WARNING LETTER
CMS# 539273
UNITED PARCEL SERVICE
w/DELIVERY CONFIRMATION
October 25, 2017
Tom Henkemans
President
ProSun International, LLC
2442 23rd St N
Saint Petersburg, FL 33713-4018 US
Dear Mr. Henkemans:
During an inspection of ProSun International, LLC, located in Saint Petersburg, Florida, conducted from August 01, 2017 through August 04, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of sunlamps/ tanning beds to include the ProSun SunDream tanning bed. Your firm’s tanning beds are classified as class II medical devices (formerly class I) under Product Code LEJ, Sun Tan Booth and require premarket clearance. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 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 to affect the structure or any function of the body.
This inspection revealed that your devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System Regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/.
Our investigator issued a Form FDA-483, Inspectional Observations, to Mr. Stanley G. David, Vice President of Operations at ProSun International, LLC on August 04, 2017. We received a response, dated August 21, 2017, from Mr. Stanley G. David concerning our investigator’s observations noted on the form FDA 483 that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish procedures for finished device acceptance, as required by 21 CFR 820.80(d). For example,
A. Your firm has not established a correlation between the UVA + UVB irradiance readings measured with your (b)(4) radiometer and the (b)(4) measurements performed by your supplier to demonstrate the suitability of their current maximum timer setting and exposure schedule. Your firm has identified “max” specifications for the “U.V. Reading” parameter measured during final testing; however, these “max” specifications were reportedly based on historical average readings for each different model/configuration of device and not on the (b)(4) measurements. “Max” specifications for the “U.V. Reading” are not identified on all of their Q.C. CHECK OFF LIST forms. Further, your “max” specifications do not take into account the (b)(4) accuracy specification of their (b)(4).
We have reviewed your firm’s written response and have determined that it is inadequate. Although the response stated that you have procured and received (b)(4) which have been certified and calibrated for (b)(4) readings on all ProSun International LLC tanning devices. You have not provided the correlation between the UVA + UVB (b)(4) readings obtained from your tanning bed supplier with that of your (b)(4). Your firm has also not provided high and low limits for your tanning devices and the testing/QC check off sheets in relation to your new meters. According to your firm’s response, you will continue to use existing QC Sheets and meters until these conversions are completed.
B. Your “100% TIMER AND UV EXPOSURE TEST PROCEDURE” (Q310-002, Rev 0 dated 03/08/2016) does not require that measurements taken on the benches of your tanning beds be taken in contact with the acrylic of the bed as your procedure indicates that all measurements be taken within (b)(4) of the acrylic.
We have reviewed the firm’s written response and have determined that it is inadequate. Although the response stated that Procedure Q31 0-002, Rev 0 is being revised and reissued to show measurement distance with the new (b)(4) which will be set at (b)(4) from all acrylics for canopy or booths and (b)(4) for the bench. Your response does not indicate how you will ensure that accurate and repeatable measurements are taken at (b)(4) (i.e. using fixture or tool) and avoid visually estimating as was observed during the inspection at your facility.
C. Records of finished device functional testing were found to be inadequate as follows;
1. No UV reading for a PROSUN Onyx unit (SIN: UN032SLI2W0022).
2. No timed cycle test recorded for aX7 unit (SIN: UNX7SLIC1W0179).
3. No timed cycle test recorded for a PROSUN Onyx unit (SIN: UN032SLII2W0020).
4. No timed cycle test recorded for a CANADA PROSUN Onyx (SIN: UN032SLIJW0011).
5. No timed cycle test recorded for a ProSun V3 unit (SIN: UN42HV3C2W0354).
6. Timed cycle test recorded as 15:06 for an X7 unit labeled as a 12 minute maximum bed (SIN: UNX7LSLIC4U001 0). The DHR for this unit identifies a UV reading of "(b)(4) "for the canopy and "(b)(4) "for the bench. Your firm's maximum tolerance for this specification was reported as "(b)(4)".
7. A UV reading of "39" is reported in the DHR for an XJO unit (SIN: IPX10SLIC2W0035). Your firm's maximum tolerance for this specification was reported as "(b)(4)".
8. Timed cycle test recorded as 12:01 for a ProSun V3 unit (SIN: UN42HV3C2W0344) labeled as a 10 minute bed.
9. Timed cycle test recorded as 10:00 for a ProSun ATF V3 unit (SIN· UN42R2AHV3C2W0080) labeled as a 12 minute maximum bed.
10. Timed cycle test recorded as 9:00 for a Luxura X3 unit (SIN: UNX336Il W0006) labeled as a 10 minute bed.
We have reviewed your firm’s written response and have determined that it is inadequate. Although the response stated that measurements were taken for items 1-5 noted above you response did not provide objective evidence of these finished device functional testing measurements. With respect to item 6, your response stated that the unit was rejected due to the (b)(4) reading of 42 however, no documentation was provided to indicate this. The final QC Checklist collected during the inspection indicated it failed the U.V. reading and was packed on 11-6-2015. With respect to item 7, your firm’s response stated that the reading of 39 was accepted and was within the acceptable tolerance of (b)(4) however, this value is not within limits specified in your firm’s procedure, 100% Timer and UV Exposure Test, Q310-002, as the max reading would be (b)(4). With respect to items 8-10, your firm states that although the beds tanning times were reduced from 12 minutes to (b)(4) the units were compliant with the maximum UV exposure levels. Your firm’s response does not address the fact that these devices did not meet established release criteria as indicated in your firm’s procedure and required as part of 21 CFR 820.80(d).
2. Failure to establish corrective and preventive action procedures, as required by 21 CFR 820.100(a). For example, your firm's "CORRECTIVE & PREVENTIVE ACTION PROCEDURE" (Q214-002, Rev 0, dated 04/24/2000) is inadequate in that:
A. It does not include requirements for analyzing quality data to identify existing and potential causes of nonconforming product and other quality problems.
We have reviewed your firm’s written response and have determined that it is inadequate. Your firm provided Corrective and Preventive Action procedure Q214-002, however it does not identify what quality data will be analyzed or how this will be performed (i.e. statistical methodology) as required by 21 CFR 820.100(a)(1).
B. It does not include requirements for verifying or validating the corrective or preventive action to ensure that the action does not adversely affect the finished device. Additionally, your procedure states that effectiveness is verified during subsequent internal quality system audits.
We have reviewed your firm’s written response and have determined that it is inadequate. Your firm’s response continues to indicate that the effectiveness of corrective and preventative actions will be performed during internal quality system audits. However, it does not provide adequate instruction on when these effectiveness checks will be performed as well as how they will be performed. Moreover, your firm’s Corrective and Preventive Action procedure Q214-002 does not specify how actions taken to correct and prevent nonconformance or other quality problems will be deemed effective. This includes the establishment of effectiveness criteria that will used to determine by objective evidence that the actions taken to correct and prevent the recurrence of nonconforming product and other quality problems were effective. In addition, your firm’s response did not include objective evidence to support the closing of CAPAs to correct observations noted during most recent inspection and that were deemed effective.
C. It does not identify actions needed to correct and prevent the recurrence of nonconforming product and other quality problems.
1. Your firm did not document corrections implemented in response to the Warning Letter received dated 09/16/2015 in accordance with your "CORRECTIVE & PREVENTIVE ACTION PROCEDURE" (Rev 0 dated 04/24/2000). Your firm implemented corrective actions in response to the Warning Letter to your SunDream tanning bed, which is labeled as either a 20 or 30 minute maximum bed, that involved design changes and a field correction in which an updated knob and updated labeling was sent to approximately (b) (4) customers. However, your firm failed to correct the issue identified in the Warning Letter involving the labeled 30 minute Maximum Recommended Exposure Time (MRET) which was found to be up to three times higher than what is recommended by FDA for this tanning bed. An updated User’s Manual for the 30 minute bed identified as “revised 12/11/2015” was reportedly provided to approximately (b)(4) customers of this home-use product and the MRET time remained as 30 minutes in this manual.
We have reviewed the written response and have determined that it is inadequate. Your firm’s response has not identified actions to correct and prevent the recurrence of the problem identified. As noted above, tanning beds that were identified to be out of specification and meeting Maximum Recommended Exposure Time (MRET) were distributed and continue to be available for use.
3. Failure to establish procedures for document control, as required by 21 CFR 820.40. For example,
A. your firm has not implemented the requirements in your "DOCUMENT CONTROL PROCEDURE" (Q205-001, Rev 1, dated 03/10/2003) in that:
1. Your procedure requires maintenance of a Master Procedure and Form Log. You do not maintain this log.
2. There are different variations of your firm's "Q.C. CHECK OFF LIST" for each tanning bed model/configuration and these documents are not identified with a "procedure number and revision level" as required by your procedure. Further, these documents include a "Revised on" date, which was identified as the date in which the document was printed and is not related to revision of the document.
3. A manufacturing procedure for your V3 160 Watt 230v tanning bed is an uncontrolled document.
B. your firm has not implemented the requirements in your “DOCUMENT CHANGE REQUEST” procedure (Q305-003, Rev 0 dated 04/24/2000) in that:
1. Changes made to your “Q.C. CHECK OFF LIST” for the SunDream tanning bed on 07/27/2017 were not documented on a DCR record.
2. Changes made to your “Q.C. CHECK OFF LIST” for the ProSun V3 tanning bed on 10/26/2016 were not documented on a DCR record.
We have reviewed your firm’s response and we cannot determine the adequacy of your firm’s response because you have not provided your firm’s revised Document Control procedure Q205-001, Rev.2 for review. In addition, your firm has not identified complete and appropriate corrective actions to remedy the deficiencies identified during the inspection. This includes the disposition of uncontrolled procedures in use at your facility.
4. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm's "HANDLING CUSTOMER COMPLAINTS PROCEDURE" (S214-001, Rev 3 dated 04/04/2012) is inadequate in that:
A. It lacks the requirement that complaints be evaluated to determine whether the complaint represents an event, which is required to be reported to FDA under 21 CFR 803. Further, your firm does not evaluate complaints for MDR reportability.
B. It lacks the definition of “complaint” to ensure proper identification of complaints.
We cannot determine the adequacy of your firm’s response since the Handling Customer Complaints procedure S214-001, Rev.3 that you stated will be revised to Q214-001, Rev.4 by August 31, 2017 has not been provided for review. In addition, your firm response states “REQUEST THIS ITEM TO BE CLOSED OUT AS COMPLETED…”; however, no objective evidence has been provided to show these corrective action have been implemented.
5. Failure to establish procedures to control environmental conditions, as required by 21 CFR 820.70(c). For example, your firm does not have procedures to control Electrostatic Discharge (ESD) during board assembly in production.
We cannot determine the adequacy of your firm’s response. Although your firm stated that you have purchased ESD equipment and work instructions are being created you have not provided objective evidence to show these corrective action have been implemented.
6. Failure to maintain a device master record, as required by 21 CFR 820.181. For example,
A. Your firm's assembly instructions included as part of your DMR for the SunDream device are written in Dutch.
B. Current versions of product labeling for the SunDream are not maintained in the DMR.
C. Your firm does not maintain current diagrams for your tanning beds to specify the location of labels. There is no diagram to specify the location of labels for stand-up style tanning beds.
We cannot determine the adequacy of your firm’s response. Although your firm stated that that Device Master Records have been created for each device you have not provided objective evidence to show these corrective action have been implemented.
7. Failure to establish procedures for quality audits, as required by 21 CFR 820.22. For example, your firm's "INTERNAL QUALITY SYSTEM AUDIT PLANNING AND PROCEDURE" (Q217-001, Rev 0 dated 04/24/2000) is inadequate in that audit criteria is based on ISO 9001 requirements and is not specific to meeting 21 CFR 820 requirements.
We cannot determine the adequacy of your firm’s response. Although your firm stated that the Internal Quality System Audit Planning procedure Q217-001, Rev.O has been revised to Q217-001, Rev.1, which now includes the references to the 21 CFR 820 requirements you have not provided the procedure for review. In addition, your firm has not provided objective evidence that the corrective actions identified in your firm’s response have been implemented.
Our inspection also revealed that the ProSun SunDream tanning bed is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
1. Failure to submit a written Report of Correction or Removal to FDA for a medical device correction or removal initiated to reduce a risk to health or remedy a violation of the Act caused by the device which may present a risk to health, as required by 21 CFR 806.10. For example, your firm conducted a field correction of the SunDream residential beds that were labeled with a maximum exposure time of 30 minutes, nearly three times in excess of the FDA recommended maximum exposure time as referenced in CDRH 8/21/86 Letter re: Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products https://www.fda.gov/downloads/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/UCM192707.pdf . A customer letter was sent out dated 02/21/2015 to all customers of the SunDream tanning bed. The letter identified that the following changes were being made to the customer’s SunDream tanning bed:
a. A new timer knob would be provided for the customer to install on his/her device. The previous design of the timer knob did not allow the user to see the exact minute count as the knob was too large and covered up the numbers on the dial. The new knob is smaller and exposes the numbers that were already on the device. The numbers were originally applied as a sticker/label. The sticker/label with the numbers corresponding to minutes did not change. As such, this further confirmed that the original 30-minute maximum beds remained as 30-minute maximum beds.
b. Updated danger and warning labeling was provided which was previously identified as having the incorrect verbiage from the regulation.
c. A new label was provided which states that no one under the age of 18 should use the tanning equipment.
d. An updated exposure label was provided to identify “compatible” lamps for use with the device. In the Warning Letter dated 09/16/2015, the SunDream sampled by Winchester Engineering Analytical Center (WEAC) was inclusive of lamps, which were not identified as compatible on the exposure sticker/ label.
e. An updated manual was provided to include copies of required labeling that was amended as described above.
There are (b)(4) SunDream devices in the field affected. Of the (b)(4) beds were 30-minute max beds and (b)(4) were 20-minute max beds and all customers were residential users of the device.
Your firm’s corrective action taken in response to FDA’s findings after sampling and the issuance of a Warning Letter for the SunDream device is inadequate in that the issue of the 30-minute maximum exposure time was not resolved. The firm did not submit a written report to FDA of the correction as required by 21 CFR 806 nor has it corrected the problem of over exposure.
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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations 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) 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 written response should be sent to the Director of Compliance, Blake Bevill via E-mail correspondence to ORADevices2FirmResponse@fda.hhs.gov. Refer to the Unique Identification Number (CMS Case # 539273) when replying. If you have any questions about the content of this letter, please contact Compliance Officer, Rafael Padilla via email at Rafael.Padilla@fda.hhs.gov or by phone at (312) 596-4212.
During the inspection, the investigator also noted and discussed the need to maintain written MDR procedures that provide instructions for electronic MDR reporting. Please ensure that your firm’s "FDA ADVERSE EVENT REPORTING PROCEDURE" (Q202-002, Rev 0 dated 03/20/2003) incorporates the requirements described below.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule were effective on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
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.
Sincerely,
/S/
Kathleen M. Sinninger
Acting Program Division Director
Office of Medical Device and Radiological Health
Division 2 - Central