- Delivery Method:
- VIA EMAIL AND UNITED PARCEL SERVICE
- Medical Devices
Recipient NameAmy J. Aarons
- Med Pen Concepts, LLC
800 W Cummings Park
Woburn, MA 01801
- Issuing Office:
- Center for Devices and Radiological Health
September 15, 2022
Dear Ms. Aarons:
During an inspection of your firm located at 800 W Cummings Park, Woburn, MA 01801 conducted on five dates from April 5, 2022, through April 13, 2022, investigators from the United States Food and Drug Administration (FDA) observed that your firm is a manufacturer of “Plasma MD” and “Plasma +” branded products intended to improve the appearance of skin by stimulating the production of collagen and other proteins. Under section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h)(1), each of these products is a device because it is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, which is 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.
We received a response from Scott Blood, Director of Regulatory Services, MEDIcept, Inc., on behalf of your firm, dated April 28, 2022, concerning our investigators’ observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below as appropriate in relation to the noted concerns.
As an initial matter, we note that evidence collected during the inspection, including product packaging and labels, user manuals, and brochures, and product labeling on your firm’s website at http://PlasmaConcepts.com, reveal that these products are devices within the meaning of the Act. For example, a review of your firm’s website, http://PlasmaConcepts.com (last accessed on June 09, 2022 and July 01, 2022), revealed the following claims:
- “This handheld device looks like a pen, but it’s actually a state-of-the-art tool that uses plasma, a naturally occurring ionized gas, to combat wrinkles and tighten sagging skin on the face and body.”
- “PlasmaMD works to improve skin by stimulating the production of collagen and elastin, the proteins that keep skin firm and supple.”
- “This treatment is also called fibroblast therapy or ‘fibroblasting,’ because it stimulates the fibroblast cells that produce this new collagen and elastin.”
- “[I]t works by emitting plasma energy, which reacts with the naturally occurring nitrogen molecules creates an energetic burst in the shape of an arc, creating a microinjury in the top layer of skin as well as heating up the dermis, where it causes collagen fibers to contract."
- “Many of today’s physicians are using PlasmaMD to target the eye area, including the upper eyelids, lower eyelids and crow’s feet.”
- “Some physicians are using PlasmaMD as a non-surgical alternative to traditional blepharoplasty, performing what they refer to as ‘non-surgical eyelid lifts.’”
- “PlasmaMD creates controlled micro-injuries to the skin, which results in some immediate firming. These micro-injuries stimulate the body’s natural wound healing response, triggering the growth of new collagen and elastin in the weeks and months following treatment.”
- “PlasmaMD has low risk of side effects and minimal downtime when compared to more invasive surgical options.”
- “These controlled microinjuries promote a long-term firming, tightening and smoothing through the skin’s own natural healing response.”
- “PlasmaMD’s unique plasma arc precision reduces unwanted and unnecessary damage to the skin surrounding the treatment area, reducing downtime and risk.”
Based on these claims, among other things, the products listed are intended to affect the structure or any function of the body (e.g., tightening and smoothing skin; lessening the appearance of lines or wrinkles) and are therefore devices within the meaning of the Act. Indeed, your firm has acknowledged the same, with Mr. Blood writing that, on or around June 1, 2021, “it became apparent that the device, marketing [sic] with medical device claims, would require some form of regulatory support for premarket notification,” and that “it became apparent that the devices are indeed considered medical devices” subject to medical device regulations.
FDA’s concerns with respect to these devices include, but are not limited to, the following:
Adulteration under Section 501(h) for Failure to Conform with Current Good Manufacturing Practice Requirements
This inspection revealed that these 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.
1. Failure to adequately establish and maintain procedures for the identification, documentation, validation, or (where appropriate) verification, review, and approval of design changes before their implementation, as required by 21 CFR § 820.30(i).
Your firm’s design change procedure, QOP-73-03, Control of Design Changes (Rev. A; Effective Date: 7/19/2019), was not followed when your firm-initiated changes to the tips used with the plasma pens. These changes include changing the tip from sterile to non-sterile and a change to a new tip manufacturer from a different country.
Further, your firm’s activities involving this design change to include identification, documentation, validation, or (where appropriate) verification, review, and approval of the change were not documented. This documentation is required in section 1.1 of your QOP-73-03 procedure in which it states: “Design changes are initiated, reviewed and implemented in (b)(4) Change Control module using electronic form EF-390-1 Change Request”.
We acknowledge your commitments to perform several corrective actions to include initiation of a CAPA to address this 483 observation, completing a design change request to document the tip design change, conduction of a risk assessment of the tip change, implementation of the tip change upon approval, completion of a document change request, updates to the design history file, and management of inventory per risk assessment results and actions from design change request. However, none of your promised actions have been completed. In your response, provide any timeframe updates for the activities promised as well as the results of your promised corrective actions as they become available.
2. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR § 820.100(a). Specifically,
Your firm’s CAPA procedure, QOP-85-03, Corrective and Preventive Action (Rev. A; effective date: 8/20/2019), includes the following requirement in section 3.1: “CAPAs are initiated and processed in the (b)(4) CAPA module using electronic form EF-130-1 Corrective and Preventive Action”. Your firm initiated a change to improve the power control of your plasma devices. This change was not conducted or documented in accordance with your CAPA procedure.
We acknowledge your commitments to initiate a CAPA to address the (b)(4) distributed devices, conduct a risk assessment for the (b)(4) distributed devices, and to manage inventory disposition per risk assessment and CAPA actions. However, your response does not address if you will be initiating a corrective and preventive action for your firm’s decision to change to an improved power control for the plasma devices. Further, none of your promised actions have been completed. In your response, provide any timeframe updates for the activities promised as well as the results of the promised corrective actions as they become available.
3. 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.
Your firm’s complaint handling procedure, Complaints, (QOP-85-02; Rev. B; effective date 11/15/2019), includes the following requirement in section 1.2: “Complaints are recorded by Customer Service. in (b)(4) Complaints module using electronic form EF-190-1 Complaint”. Your firm has received 17 complaints since September of 2019 and did not utilize electronic form EF-190-1 for the documentation of complaints. Rather your firm utilized a “Credit Memo” document (no form number or effective date) for complaint files. For these seventeen complaint files created since the establishment of your procedure, some or all the following information was not routinely recorded as required by 21 CFR § 820.198(e):
(1) The name of the device;
(2) The date the complaint was received;
(3) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used;
(4) The name, address, and phone number of the complainant;
(5) The nature and details of the complaint;
(6) The dates and results of the investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.
We acknowledge your commitments to update procedure QOP-85-02, reassess and update all 17 complaints taken since September 2019 per your procedure once updated, and to train your quality complaint unit on the updated complaint procedure and record-keeping processes. However, none of your promised actions have been completed. In your response, provide any timeframe updates for the activities promised as well as the results of your promised corrective actions as they become available.
4. Failure to adequately establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented, as required by 21 CFR § 820.80(b). Specifically,
Your firm’s procedures, QOP-74-02, Purchasing (Rev. B; Effective Date: 11/15/2019) & QOP-74-03, Verification of Purchased Product (Rev. A; Effective Date: 7/25/2019) were not followed in that activities surrounding acceptance of devices were not documented showing that your firm is inspecting, testing, or otherwise verifying that devices received from contract manufacturers conform to specified requirements.
We acknowledge your commitments to perform corrective actions to include initiation of a CAPA to address this 483 observation and the retrospective assessment and acceptance or all devices and tips in inventory. However, none of these promised actions have been completed. In your response, provide any timeframe updates for the activities promised as well as the results of your promised corrective actions as they become available.
5. Failure to maintain device history records (DHR's), as required by 21 CFR § 820.184.
Your firm does not maintain device history records (DHR’s) for the plasma devices received from contract manufacturers which are then further packaged with instructions for use (IFUs) and other products as part of a convenience kits that is then distributed. DHR’s have not been created to include or refer to location of, the following information: (a) The dates of manufacture; (b) The quantity manufactured; (c) The quantity released for distribution; (d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR; (e) The primary identification label and labeling used for each production unit; and (f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used for the (b)(4) plasma devices your firm has sold since the beginning of your firm’s sales of these products in September 2019.
We acknowledge your commitments to perform corrective actions to include initiation of a CAPA to address this 483 observation, updating your associated procedures and forms, and the retrospective performance of DHR’s for all devices. However, none of these promised actions have been completed. In your response, provide any timeframe updates for the activities promised as well as the results of your promised corrective actions as they become available.
6. Failure to adequately establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. The dates and results of quality audits and reaudits shall be documented, as required by 21 CFR § 820.22. Specifically,
Your firm’s quality audit procedure, QOP-82-02, Internal Quality Audits (Rev. A; Effective Date: 8/20/2019), covers the process for conducting internal audits of your quality system to include the requirement in section 1.2 that states: “Each quality system process is audited at least (b)(4)”. During the inspection, the Chief Strategy Officer stated that one internal audit had been performed since operations for the plasma devices began in September 2019. Further, your Chief Strategy Officer stated this audit was not documented.
We acknowledge your commitments to perform several corrective actions to include initiation of a CAPA to address this 483 observation, the development and scheduling of an internal audit plan, assignment of internal auditors, and conduction of an internal audit. However, none of your promised actions have been completed. In your response, provide any timeframe updates for the activities promised as well as the results of your promised corrective actions as they become available.
7. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented, as required by 21 CFR § 820.20(c). Specifically,
Your firm’s management review procedure, QOP-56-01, Management Review (Rev. A; Effective Date: 7/9/2019), states in section 1.2 that management reviews are conducted at least (b)(4). Your firm has not conducted a management review since medical device operations began in 2019.
We acknowledge your commitments to perform several corrective actions to include initiation of a CAPA to address this 483 observation, conduction of a Management Review for year 2022 and the scheduling of a subsequent 2023 Management Review. However, none of your promised actions have been completed. In your response, provide any timeframe updates for the activities promised as well as the results of your promised corrective actions as they become available.
Adulteration under Section 501(f)(1)(B) for Failure to Have an Approved PMA or IDE
Our inspection also revealed that the Plasma MD and Plasma + devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not for these devices 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).
Misbranding under Section 502(o) for Failure to Submit a 510(k)
The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not timely notify the agency of its intent to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of the devices, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
The notification required by section 510(k) of the Act is not required for a device for which a PMA is pending before the agency. 21 CFR 807.81(b)(1). The kind of information that your firm could submit in order to obtain approval or clearance for the devices is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and respond as appropriate.
Misbranding under Section 502(c) for Failure to Have Compliant Labeling
The inspection revealed that your devices are also misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of section 519 of the Act, 21 U.S.C. § 360i, to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a), which was promulgated under authority of section 519 of the Act, among other provisions, requires, with exceptions not relevant here, that the label of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. The labels of the Plasma MD and Plasma + devices do not bear such a UDI. For example, the labels for these devices do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, there is no UDI presented in easily readable plain-text (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses automatic identification and data capture (AIDC) technology (see 21 CFR 801.40(a)(2)).
Misbranding under Section 502(t)(2) for Failure to Submit Required Information to GUDID
In addition, your devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting the devices. In particular, 21 CFR 830.300(a) and 830.320(b), both of which were promulgated under section 519 of the Act, among other provisions, require, with exceptions not relevant here, that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI. Your firm is a “labeler” within the meaning of 21 CFR 830.3, and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these devices.
The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).
* * *
We request that your firm immediately cease any activities that result in the misbranding or adulteration of the devices, such as their commercial distribution as discussed above.
This letter notifies you of our concerns and provides you an opportunity to address them. Your firm should take prompt action to correct any violations.
Failure to adequately address the matters discussed in this letter may result in legal action being initiated by the FDA without further notice. These actions may include, but are not necessarily limited to, seizure, injunction, and civil money penalties.
Other federal agencies may take your compliance with the Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System Regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been corrected. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. More information on processes for persons denied a CFG can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-requestreview-fdas-decision-not-issue-certain-export-certificates-devices.
We ask that you 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 address the concerns noted in this letter. Include documentation of any corrections and/or corrective actions (which should address systemic problems) that your firm has taken. If any corrections and/or corrective actions your firm plans to take will require more time, please include a timetable for implementation of those activities. If any corrections and/or corrective actions your firm plans to take cannot be completed within fifteen business days, state the reason for requiring additional time and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all concerns included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent to: Gina Brackett, Director of Compliance Branch, at firstname.lastname@example.org. Refer to CMS # 632974 when replying. If you have any questions about the contents of this letter, please contact: Sean Moynihan, Compliance Officer, at 410-779-5134 or email@example.com.
Finally, you should know that this letter is not intended to provide an all-inclusive list of any deficiencies at your firm’s facility or associated with your firm’s devices. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific concerns noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be indicative of, or in addition to, other issues with your firm’s devices, manufacturing and quality management systems. Your firm should investigate and determine the causes of any deficiencies, and take prompt actions to correct any violations and bring the products into compliance.
Binita S. Ashar, MD, MBA, FACS
OHT 4: Office of Surgery and Infection Control
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
Division 1 - East
Brendan J. Aarons, Chief Strategy Officer (CSO), Med Pen Concepts, LLC
Donald W. Shooter, Chief Executive Officer (CEO), Med Pen Concepts, LLC