|Issuer:||Dallas District Office|
|Issued:||Jan. 21, 2011||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
RETURNED RECEIPT REQUESTED
Mr. Steven C. Shanks
2021 Commerce Drive
McKinney, Texas 75069
Dear Mr. Shanks:
During an inspection of your firm located in McKinney, TX, on November 17 through November 24, 2009, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures markets and distributes the Zerona MLS laser scanner for use in liposuction and body contouring. Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), Zerona MLS laser scanner is a device because it is 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.
1. Your Zerona Medical laser is adulterated under section 501 (f)(1)(B) of the Act, 21 U.S.C. § 351 (f)(1)(8), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your Zerona Medical laser is also misbranded under section 502(0) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. § 807.81(a).
a. Our review of your firm's press releases posted on your website at
titled "Erchonia Presents New Laser Studies A2010 ASLMS Conference" revealed that they contain statements about clinical studies that represent or suggest that your Zerona laser devices are effective for new indications. A major change or modification in the intended use of the device requires a premarket notification submission, as required by 21 C.F.R. § 807.81 (a)(3)(ii). For example:
i. "Erchonia will be presenting a study it conducted using low level lasers to treat late stage Parkinson's disease.... Eight volunteers between 18 and 80 years with late stage PO participated in the non-controlled, non-randomized study and received low level laser treatments daily for two weeks.... All participants demonstrated a decrease in VAS for baseline to study endpoint."
ii. 'The second study Erchonia plans to present shows how low-level lasers may reduce low-density lipoprotein (LOL) .... Forty one patients between 18 and 65 years participated in the noncontrolled, non-randomized study. Participants received a 40 minute ZERONA laser treatment three times a week for two weeks... This study suggests that low level laser therapy may serve as a non-invasive way to reduce LOL in two weeks."
iii. "The third study explores how ZERONA laser impacts leptin levels, the hormone linked to hunger. Twenty volunteers between the ages of 18 and 65 participated in Erchonia's non-controlled, non-randomized study. ... All participants demonstrated a reduction in leptin levels compared to their baseline - on average, a 50% decrease. Since leptin levels are associated with hunger, the study shows how low level laser technology may noninvasively suppress the appetite."
b. Another press release titled, "Studies Shows Fat Reduction Laser Reduces Hunger and LOL Levels," dated May 5, 2009, contains the following statements:
i. "Erchonia Medical, the global leader in low level laser healthcare applications, announces today that its newest laser for body sculpting, Zerona, has been clinically shown to reduce the levels of the hunger-hormone, leptin, and lipoprotein (LOL). A 22 participant pilot study revealed that Zerona not only reduced circumferal inches ... but also lowered all patients' leptin levels and reduced low-density lipoprotein number in over 50% of the patients in just two weeks."
ii. "Suppressing the very hormones that may cause individuals to be overweight or obese can further aid Zerona patients with their weight-loss goals."
iii. "In addition to reducing inches, suppressing hunger, and reducing LDL levels... "
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration 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 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 (21 CFR Part 820) 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, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. 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.
In addition, FDA has noted nonconformances with the following Current Good manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR Part 820. We received a response from Debra J. Engolia, IP Manager, dated December 7, 2009, concerning our investigator's observations noted on the Form FDA 483 (Inspectional Observations) that was issued to you. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action to include analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product and other sources of quality data to identify existing and potential causes of non-conforming product or other quality, as required by 21 C.F.R. § 820.100(a)(1).
For example, your firm's SOP 8C-002 Rev. 1, dated October 4, 2006, "Trending of Data Feedback" that defines problems associated with quality data feedback on complaints for analysis and evaluation of non-conforming products was not implemented. Your firm could not provide the
trending reports for change requests, complaints, or reports for the months September 2009 or October, 2009.
Your firm's response is not adequate because it provided no documentation for the months of September 2009 or October 2009 or provided any form of guarantee that SOP 8C-002 has been properly implemented.
2. Failure to establish and maintain a procedure that ensures the review and evaluation of all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 C.F.R. § 820.198(b).
For example, your firm failed to evaluate, investigate or document the rationale for not investigating complaints that represented possible failures for the Zerona Medical laser to meet any specifications:
a. Complaint No. 2230 showed that the flex arm of a Zerona device was broken.
b. Complaint No. 2013 showed that the device caught fire.
c. Complaint No. 2278 and 2277 showed that a screw was found loose on an MLS Scanner laser and the device was non-functional.
Your firm's response, dated December 7, 2009, is not adequate because your firm has only indicated that they will revise the existing SOPs to include an inspection checkpoint that will insure resolution of the problem, and that this will be completed by February 24, 2010. Your firm did not address complaint No. 2230, 2213, 2279, and 2277. Additionally, no systematic corrective action was addressed or a retrospective evaluation of other past complaint files was performed.
3. Failure to validate computer software for its intended use in production according to established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented as required by 21 C.F.R. § 820.70(i). For example, your firm failed to validate, according to established procedures, the automated mills and lathes that are used in the manufacturing of components for the PL5 2008 medical laser. Your firm installed
automated mills and one automated lathe during December, 2006 but your firm could not provide an established validation protocol for the validation of the automated systems or provide any documentation that showed the systems and their controlling software that were used in the manufacture of metal and plastic components of the PL5 Medical Laser were validated.
Your firm's response is not adequate because it only indicates that a new SOP detailing the method for validation is yet to be established and this process is to be completed on March 24, 2010. Your firm did not provide FDA a copy of the SOP for review.
4. Failure to establish and maintain adequate procedures for the identification, documentation, validation, or where appropriate verification, review and approval of design changes before their implementation, as required by 21 C.F.R. § 820.30(i).
For example, your firm's design control SOP-7A-001 Rev. 2 and SOP-4B-001 Rev.3 do not address the requirements for or the procedures to be followed to verify or validate a design change. A change control was made to the
design of the PL5 2008 medica/laser. Your firm failed to verify or validate the change to the
design made to the PL5 2008 medical laser. The change was initiated after your firm identified
failures through the complaint/repair process. The change was documented and controlled through Change Request 39-08-PL5 which was subsequently closed but your firm was unable to provide documentation to show that the verification or validation of the change was conducted.
Your firm's response, dated December 7, 2009, is not adequate because it did not provide documentation to show verification or validation for the
design changes of the PL5 2008 medical laser.
5. Failure to establish and maintain adequate procedures for validating the device design that includes software validation and risk analysis, where appropriate, as required by 21 C.F.R. § 820.30(g). For example, your firm's "Risk Analysis Form RA-PL5 Rev. 2," dated July 22, 2002, is the only document that identifies specific procedures to conduct risk analysis. The form defines frequency and severity to determine the risk and lists the hazards that must be considered. However, your firm failed to adequately perform risk analysis in accordance with the form's procedural requirements.
a. The risk analysis for the Erchonia PL5000 (PL5 and PL5 2008) identified "non-ionizing radiation" as a hazard. Your firm identified this hazard as not applicable based upon the frequency of occurrence of less than (b)(4) in (b)(4) uses.
b. The risk analysis for the Erchonia PL5000 (PL5 and PL5 2008) identified "accidental mechanical damage" as a hazard. Your firm identified this hazard as not applicable with a frequency of occurrence of less than
c. The risk analysis for the Erchonia PL5000 (PL5 and PL5 2008) identified "reasonable foreseeable misuse" as a hazard. Your firm identified this hazard as not applicable with a frequency of occurrence of less than (b)(4) in (b)(4) uses.
Your firm's response is not adequate. It indicates that, though risk analysis is performed as part of the design control, you do not have a specific SOP and/or other documentation that defines the procedure used for performing risk analysis
following the lifecycle of the device. Your firm stated that an SOP would be written that defines the risk analysis requirements by February 24, 2010.
6. Failure to establish and maintain adequate procedures for acceptance of incoming products. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented, as required by C.F.R. § 820.80(b). For example, your firm failed to define and implement complete incoming component inspection procedures.
a. Your firm's QC receipt inspection SOP 70-001 Rev. 1 requires a visual inspection or testing of incoming components or products and specialty items, such as
. Your firm was unable to provide documentation to show that
were tested upon receipt. All of the
were subsequently used in the manufacturing of the medical laser devices.
b. Your firm's QC receipt inspection SOP 7D-001 Rev.1 failed to define specific acceptance levels or establish how much product is rejected if any non-conformances are found.
Your firm's response, dated December 7, 2009, is not adequate because it admits that it has yet to fully implement the SOP for performing inspections and that this element was to be fully completed by January 24, 2010.
7. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented, as required by 21 C.F.R. § 820.90(a).
For example, your firm failed to adequately control and document nonconforming products identified by your firm as required by SOP 8A-001 Rev. 2.
a. On July 31, 2009, your firm identified a non-conformance component of a PL5 2008 device (serial number
but the product was shipped to a customer on July 8, 2009. There was no record of the device being returned to your firm during the period.
b. On July 31, 2009, your firm identified a non-conformance component of a PL5 2008 device (serial number
The product was shipped to a customer on July 20, 2009, and there was no record to show that the device was returned to your firm and the disposition of the non-conforming product.
Your firm's response, dated December 7, 2009, is not adequate because it only indicates that you will revise the existing SOP to insure that complaints on nonconforming products and repairs performed are correctly recorded and that the
revision will be completed by February 24, 2010. Your firm did not provide FDA their revised SOP for review. No systematic corrective actions were addressed or retrospective evaluation of other past non-conformance records.
8. Failure to establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, as required by 21 C.F.R. § 820.250(b). For example, your firm's QC receipt inspection SOP 70-001 Rev.1 did not identify the sampling levels used for inspecting incoming components.
Your firm's response, dated December 7, 2009, is not adequate because it admits you are yet to fully implement the SOP for performing inspections and that this element was to be fully completed by January 24, 2010.
9. Failure to establish adequate procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 C.F.R. § 820.25. For example, your firm failed to document the training of the Quality Control technician. The training record for your firm's Quality Control Technician employees had no documentation that the employees received the required training in nineteen standard operating procedures that are required by your firm's training matrix.
Your firm's response is inadequate because it only indicates that you will revise the SOP to insure that employee training is properly documented and you will revise the SOP documentation forms to reflect the fact that employees received the necessary training as required by 21 C.F.R. § 820.25(b). It provided no evidence that these employees were properly retrained. No systematic corrective actions were addressed or retrospective evaluation of other past training records.
Your response should be sent to Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suit 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Reynaldo R. Rodriguez, Jr.
Dallas District Director