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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Energist Limited 12/4/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, MD 20993

DEC 4, 2012

WARNING LETTER

 
VIA UNITED PARCEL SERVICE
 
Jonathan Prutton
Chief Executive Officer
Energist Limited
2 Park Pavilions, Clos Llyn Cwm
Enterprise Park
Swansea, SA6 8QY United Kingdom 

Dear Mr. Prutton: 

During an inspection of your firm located in Swansea, United Kingdom on May 21, 2012, through May 24, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures or distributes the Ultra Plus Variable Pulsed Light (VPL), iPulse i150, i200, and i300 Pulsed Light Systems, and a nozzle for the Portrait Plasma System.  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 function of the body. 

Our inspection revealed that your firm’s devices are 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 803 - Medical Device Reporting.  We received responses from Rob Davies, Regulatory Affairs Officer, dated May 29, 2012, and June 27, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations 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:  

Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s procedure titled “Quality Assurance Procedure, QAP 13 - Adverse Incident Reporting, Form RF524, QAP Issue 8”, the following issues were noted:

1. There is no evidence that QAP 13, Issue 8 has been implemented. For example, there is no “Prepared by” or “Approved by” date.

2. QAP 13, Issue 8 does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to the MDR requirements.  For example, the procedure does not address:

a. Definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,”  “serious injury,” and a definition for reference to the term “reasonably suggests,” found in 803.20(c)(1).
b. QAP 13, Issue 8 does not stipulate that your firm must report to the FDA no later than 30 calendar days after the day that it becomes aware of information that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

3. QAP 13, Issue 8 does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed: 

a. The address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
b. Circumstances under which an event must be submitted as a 30-day report.
c. The circumstances under which your firm must submit a supplemental or follow-up report and the requirements for such reports.

We reviewed your firm’s responses dated May 29, 2012, and June 27, 2012 and conclude they are not adequate.  Although your firm revised its procedure and submitted a copy for FDA in its response, the revised procedure still fails to meet the requirements of 21 CFR 803.17. After reviewing your firm’s revised MDR procedure titled “Quality Assurance Procedure QAP-13 - Adverse Incident Reporting Form RF524, QAP Issue 9”, the following issues were noted:

1. There is no evidence that your firm’s MDR procedure, QAP 13, Issue 9 has been implemented. For example, there is no “Prepared by” or “Approved by” date for the firm’s MDR procedure.

2. QAP 13, Issue 9 does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to the MDR requirements.  For example the procedure does not address:

a. Definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,”  and a definition for  the term “reasonably suggests,” found in 803.20(c) (1).
b. The definition of “MDR reportable event” is not consistent with the definition in 21 CFR 803.3.

3. QAP 13, Issue 9 does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed: 

a. The address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
b. Section 7, titled “FDA Specific Requirements”, references submission of 5 day reports to FDA. However, the reference does not correctly identify the timeframe for submitting 5-day reports to FDA as “work” days as required by 21 CFR 803.53(a).

4. QAP 13, Issue 9 does not include a description of how your firm will address documentation and record-keeping requirements, including:

a. Documentation of adverse event related information maintained as MDR event files.
b. Information that was evaluated to determine if an event was reportable.
c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.

If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:

http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm

If your firm wishes to discuss MDR reportability criteria based on the information noted above, it may contact the Reportability Review Team from the MDR Policy Branch at ReportabilityReviewTeam@fda.hhs.gov.
 
During the inspection, FDA learned that your firm is marketing and promoting the Ultra Plus Variable Pulsed Light System (Ultra Plus VPL) in the United States without the required marketing clearance or approval in violation of the Federal Food, Drug, and Cosmetic Act (the Act).  Specifically, the Ultra Plus VPL was cleared under K082825 with the following indications: 

“The Energist ULTRA VPL Intense Pulsed Light System  is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris.  It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.

• Intense Pulsed Light Energy / wavelengths (530 – 950 nm)

The 530 – 950 nm intense pulsed wavelengths are indicated for:
The treatment of mild to moderate inflammatory Acne Vulgaris.
The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melisma, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins, facial veins and venous malformations.

• Intense Pulsed Light Energy / wavelengths (610 – 950 nm)

The 610 – 950 nm intense pulsed wavelengths are indicated for:
The removal of unwanted hair from all skin types and to effect stable long-term or permanent hair reduction1 in skin types I – V through selective targeting of melanin in hair follicles.

• Intense Pulsed Light Energy / wavelengths (415/630 – 950 nm)

The treatment of mild to moderate inflammatory Acne Vulgaris.”

However, a review of your firm’s promotional brochures revealed your firm is marketing your Ultra Plus VPL for “skin rejuvenation” indications. 

Promotion of this device for the claim listed above represents a change or modification of its intended use under 21 CFR 807.81(a)(3)(ii).  Therefore, the Ultra Plus VPL is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), 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). The Ultra Plus VPL is also misbranded under section 502(o) 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 in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(ii). 

Additionally, during our inspection the investigator collected product labeling and promotional brochures for the iPulse i200 and i300 Pulsed Light systems.  We determined that these devices are light based devices being promoted for “treatment of acne,” use in “hair removal,” and “skin rejuvenation.”  Light based devices promoted for such indications require a premarket notification.  

A review of our records reveals that you did not obtain marketing approval or clearance before you began offering these devices for sale, which is a violation of the law. Specifically, the iPulse i200 and i300 Pulsed Light systems are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices 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 is deemed satisfied when a PMA is pending before the agency, 21 CFR § 807.81(b).  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.  The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.    

The Office of Compliance requests that Energist Ltd. immediately cease marketing and the dissemination of promotional materials for the Ultra Plus VPL, iPulse i200, and i300 Pulsed Light systems the same as or similar to those described above. 

A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.  

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/or 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 awarding 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.

Additionally, we were unable to find Energist FDA clearance numbers associated with the iPulse i150 (K083748), the iPulse i400 (K080406) and the iPulse Quadra Q4 (K071883).  These clearances are associated with another applicant.  We request you provide us with an explanation of any relationship between your firm and the other applicant’s FDA clearance numbers.

In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820.  These nonconformities include, but are not limited to, the following:

1. Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i).

For example, the process validation report for the software used in the (b)(4), including the Ultraplus devices, does not show the software version or the equipment used for the validation.

Your firm’s responses to this observation appear to be adequate.  Your firm performed a corrective action by revalidating the (b)(4) software version 1.07, by validating the software met user needs and intended uses and documenting the equipment used during the revalidation.   

2. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g).  For example:

QAP 4, Risk Management procedure, Section 4.5.3 states that the tasks to be undertaken for risk analysis include identification of intended use and characteristics related to safety, identification of hazards, identification of hazardous situations, and estimation of the risks.  Section 4.5.4 requires determination of risk reduction requirements and section 4.5.5 requires risk reduction and risk control option analysis.  The procedure refers to the current standard, BS EN 14971:2009, and does not include procedures for how to conduct each task. 

Your firm’s responses to this observation appear to be adequate.  Your firm performed a corrective action by establishing procedures describing how to perform each task as noted in Sections 4.5.3, 4.5.4, and 4.5.5 of QAP 4 Risk Management.

3. Failure to establish and maintain procedures to ensure that device history records (DHR’s) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of 21 CFR 820, as required by 21 CFR 820.184. 

For example, the device history records for the Ultra Plus devices do not include or refer to the location of the primary identification label and labeling used for each device.  Examples include device serial numbers (b)(4) and (b)(4). In addition, the device history record for serial number (b)(4) was not completed for the final assembly checks and pre final inspection.

We reviewed your firm’s responses and conclude that it is not adequate.  Your firm performed a corrective action by instituting a secondary review (double check) of paperwork reviewed by the final check employee, revising the DHR form to document the secondary review, and including copies of current labeling and the serial number label in the DHR; however, your firm did not provide evidence of systemic corrective action.

4. Failure to  ensure that each device master record (DMR) is prepared and  approved in accordance with 820.40, as required by 21 CFR 820.181.   

For example, the Ultra Plus Device Master Record was not approved prior to issuance.

The adequacy of your firm’s responses cannot be determined at this time.  Your firm explained that the Ultra Plus Device Master Record (DMR) document was actually a hardcopy DMR checklist which referred to approved, electronic documents maintained on the firm’s server.  Your firm provided the current DMR checklist as its corrective action and its systemic corrective action consisted of verifying the other hardcopy DMRs for its other devices were approved and signed and the documents referenced by the DMRs were controlled and approved per its document control system.  However, your firm did not provide documentation showing approval and signatures of the Ultra Plus DMR checklist as part of its response.

5. Failure to establish procedures for identifying training needs and ensure all personnel are trained adequately to perform their assigned responsibilities, as required by 21 CFR 820.25(b). 

For example, QAP-17 Training procedure, Section 4, requires that employees receive induction training that includes training in the procedures identified as “Need to know” on the Quality Manual & Quality Assurance procedures (QAP) Matrix.  Training records do not show that employees received training in the procedures that were identified as “Need to know” on the Quality Manual & Quality Assurance Procedures (QAP) Matrix.  An example includes employee C.H.

Your firm’s responses to this observation appear to be adequate.  Your firm performed a corrective action by creating a new Quality Assurance Procedure Matrix form to document employee training and provided four completed examples.

A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.

Your firm’s response should be sent to:

Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Operations Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993. 

Refer to CMS Case # 358418 when replying.  If you have any questions about the contents of this letter, please contact: LaShanda Long, Chief, General Surgery Devices Branch at (301) 796-5770 or fax: (301) 847-8137.
 
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 yours,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health

1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.