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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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GMR Products Inc 17-Mar-08

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

Public Health Service
Food and Drug Administration

 

Central Region
Waterview Corporate Center
10 WaterView B1vd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4906


March 17, 2008

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

Bridget Rossi
President
GMR Products, Inc.
565 Holly Drive
Franklinville, NJ 08322

08-NWJ-04

Dear Mrs. Rossi:

During an inspection of your firm located in Franklinville, New Jersey on November, 14 and November 21, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Amazing Laser Brush. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) U.S.C. 321(h), this product 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.

This inspection revealed that the device is 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 (CGMP) requirements of, the Quality System (QS) regulation found at Title 21, Code of Federal Relations (CFR), Part 820. We received a written response from Bridget Rossi, President, dated December 5, 2007 concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but not limited to, the following:

1. Management with executive responsibility has failed to ensure that an adequate and effective quality system has been fully established, implemented and maintained at all levels of the organization as required by 21 CFR § 820.20. Your firm had failed to establish a quality policy and to ensure that it is followed.

Specifically, your firm has no documented quality system procedures for the manufacturer and distribution of the Amazing Laser Brush, which would include a device master record, device history records, and acceptance activity records. Furthermore, your firm has not established procedures for performing quality audits, identifying training needs, design control, document control, purchasing controls, change control, process controls, finished device distribution, and control and disposition of non-conforming product or complaint handling.

2. Failure to establish and maintain procedures for implementing corrective and preventive action as required by 21 CFR § 820.100(a). Specifically, your firm has no written corrective and preventive action (CAPA) or complaint handling procedures for your finished Amazing Laser Brush device.

3. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications as required by 21 CFR § 820.70(a). Specifically, your firm has failed to establish and maintain process control procedures for the possible deviations from device specifications that could occur during the manufacturing process of the Amazing Laser Brush. For example, the number and positioning of the lasers could lead to deviations from device specifications as a result of the absence of written production methods, procedures, and workmanship criteria (such production controls are required).

4. Failure to establish and maintain procedures for acceptance activities as required by 21 CFR § 820.80(a). Specifically, your firm has no written procedures for incoming and finished device inspection and acceptance activities. Your firm has no written procedures to ensure that your inspection and verification activities are performed in a consistent manner. Your firm has failed to maintain records that provide evidence that the Amazing Laser Brush has gone through defined acceptance activities.

5. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met as required by 21 CFR § 820.30. Specifically, your firm has no written design control or design change procedures for your Amazing Laser Brush. Your firm has failed to establish appropriate design controls for your Amazing Laser Brush where the device may be neither safe nor effective for its intended use. For example, there was no design inputs, no record of design reviews, no records of design verification or design validation for your Amazing Laser Brush to review during the inspection of your firm.

6. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR § 820.50. Specifically, your firm has failed to establish and maintain the requirements, including quality requirements, which must be met by suppliers, contractors, and consultants for the products and services received by your firm. Your firm has failed to ensure purchased or otherwise received product or services conform to specifications. Your firm has no written procedures to ensure the acceptability of products and services for their intended uses.

7. Failure to maintain all records by this part at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturing and to employees of FDA designated to perform inspections as required by 21 CFR § 820.180. Specifically, your firm has no written procedures or work instructions for the manufacture of the Amazing Laser Brush. These records are necessary when performing any type of investigation and should be kept in a location that is reasonably accessible to both the manufacturer and FDA investigators.

Our inspection also revealed that your Amazing Laser Brush is misbranded under section 502(t)(2) of the Act, 21 U.S.C. Section 352(t)(2), in that your firm failed to furnish any material or information respecting the devices that is required by or under section 519 of the Act, 21 U.S.C. Section 360i, and 21 CFR Part 803- Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to the following:

Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR § 803.17. For example, your firm has no written MDR procedures and does not have an internal system that provides for the effective identification, communication, and evaluation of events that may be subject to (MDR) requirements. In addition, your firm does not have a standardized review process/procedure for determining when an event meets the criteria for reporting under this part.

We viewed your Web site, www.gmrproducts.com. The Web site promotes your product as a laser device that is used to grow hair. There are numerous testimonials on this web site that state that use of the Amazing Laser Brush results in hair growth. For example:

1. On January 31, 2008, the Web site http://www.gmrproducts.com/head_shot.htm contains before and after pictures of adults that show increase in hair. In addition, this Web site displays pictures of a child with a caption: "Almost a year later and young Mitchell's hair is grown completely in."

2. On January 31, 2008, the Web site, http://www.gmrproducts.com/head_shot.htm contains pictures and the comment, "These photos were posted on the website below from a user of my brush!" The Web site provides a link to the Web site, http://www.gaining-mass.com/hair-regrowth-without-drugs-t2127.htm. This Web site includes testimonies with the title "Hair re-growth without drugs"

The Amazing Laser Brush 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 device is also misbranded under section 502(o) of 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. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

We have reviewed your response and have concluded that it is inadequate because your letter dated December 5, 2007 states that the device is cosmetic and not medical. We consider your product to be a medical device. Also, your letter does not promise corrective or preventive actions.

In addition to the above violations, we note that your website also lists the following "benefits" of laser therapy:

• Biostimulation
• Increases blood supply
• Stimulates the immune system
• Stimulates nerve function
• Develops collagen and muscle tissue
• Helps generate new and health cells and tissue
• Relieves acute and chronic pain
• Anti-inflamatory
• Stimulation of wound healing

The above benefits are listed directly above a link to purchase the Amazing Laser Brush. If you promote your device for these intended uses, the information you submit to obtain approval or clearance should address these intended uses.

You 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 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 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 violations, or similar violations, from occurring again have taken. Include documentation of the corrective action you. 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 to the above violations, it has come to our attention that you are currently marketing a brush with six (6) lasers. However, during the inspection, the investigator collected a "[redacted]" dated [redacted] for a brush with [redacted] Please provide a "[redacted]" for the six (6) lasers brush you are currently marketing.

Your response should be sent to Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter please contact: Mr. Maffei, Compliance Officer at 973-331-4906.

Finally, you should know that 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 list of 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 violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely yours,

/S/

Douglas I. Ellsworth
District Director
New Jersey District Office