Inspections, Compliance, Enforcement, and Criminal Investigations
American Quality Manufacturing, Inc. 8/9/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
August 9, 2011
Mr. David L. McConnell
American Quality Manufacturing, Inc.
310 Shearer Boulevard, Suite “A”
Cocoa, Florida 32922-7248
Dear Mr. McConnell:
During an inspection of your firm located in Cocoa, Florida on March 28 - 29, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and distributes Skin Rejuvenation and Sun Tanning Products. 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 are intended to affect the structure or function of the body.
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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from you dated April 19, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you. 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 and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100. Specifically, your firm failed to ensure that CAPA procedures were provided in writing and implemented.
We reviewed your response and conclude that it is not adequate because it only states that you are in the process of implementing a corrective and preventive action. However your firm did not provided any corrections, corrective actions, or systemic corrective actions to address this specific observation.
2. Failure to establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit, to ensure that: (1) all complaints are processed in a uniform and timely manner and (2) oral complaints are documented upon receipt as required by 21 CFR 820.198(a). Specifically, your firm did not have procedures for complaint handling activities.
We reviewed your response and conclude that it is not adequate because you stated, “Other than normal maintenance complaints such as shocks, acrylics, starters, timers will not activate.” However, your firm was implementing complaint handling procedures and written complaint log. Your firm has not provided any corrections, corrective actions, or systemic corrective actions to address this specific observation.
3. Failure to establish and maintain quality requirements that must be met by suppliers, contractors and consultants including (1) evaluating and selection of potential suppliers, contractors and consultants to meet specified requirements, including quality requirements (2) defining the type and extent of control to be exercised over the product, services, suppliers, contractors and consultants based on the evaluation and (3) establishing and maintaining records of acceptable suppliers, contractors and consultants, as required by 21 CFR 820.50(a). Specifically, your firm did not have procedures for supplier controls.
We reviewed your response and conclude that it is not adequate because your firm stated it relied on its testing companies for supplier approval and evaluation, as well as finished device quality and unit approval before selling. Your firm also stated it will implement its own production and process control procedures in a log form that will include supplier approval and evaluation, DHR procedures and finished device quality unit approval prior to distribution. However, your firm has not provided a projected completion and implementation timeline for the creation of these new procedures.
4. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system as required by 21 CFR 820.22. Specifically, your firm did not have procedures for quality audits.
We reviewed your response and conclude that is not adequate because your firm stated it is a family business and discuss internal audits verbally at morning management meetings. Your firm also stated it will now devise a written method for internal audits in order to comply with the regulations. However, your firm has not provided a projected completion and implementation timeline for the creation of these new procedures.
5. Failure by 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; with documentation of the dates and results of the quality system reviews, as required by 21 CFR 820.20(c). Specifically, your firm did not have procedures for management reviews.
We reviewed your response and conclude that it is not adequate because your firm stated it will install a written management review procedure program. However, your firm has not provided a projected completion and implementation timeline for the creation of these new procedures.
6. Failure to establish and maintain adequate 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), as required by 21 CFR 820.184. Specifically, your firm did not establish DHR procedures.
We reviewed your response and conclude that it is not adequate because your firm stated it relied on its testing companies for supplier approval and evaluation, as well as finished device quality and unit approval before selling. Your firm also stated it will implement its own production and process control procedures in a log form that will include supplier approval and evaluation, DHR procedures and finished device quality unit approval prior to distribution. However, your firm has not provided a projected completion and implementation timeline for creation of these new procedures.
In addition, your firm’s website http://www.tanningonline.com/collagen.html was reviewed by an FDA investigator on March 28, 2011. According to your website,
“Renew-U Red Light Therapy: Increase your salon’s traffic with a proven anti-aging technology in the 633nm region…Naturally promotes collagen production…Activates blood flow for increased circulation…Natural Anti-Aging Treatments Prevail…”
Our inspection revealed that the Collagen Red Light Therapy Beds, specifically, the Renew-U Collagen Beds are 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) 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 CFR 807.81(b). 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.
Also, based on the findings discovered during the inspection, FDA has determined that your firm failed to establish a quality control and testing program which ensures compliance with the applicable performance standards. Sunlamp products manufactured on or after May 7, 1980, are subject to the requirements of the Federal performance standard for sunlamp products (Title 21 CFR 1040.20) as well as the general performance standard for electronic products (Title 21 CFR 1010).
Specifically, your firm failed to test all digital timers installed into your tanning beds to ensure that the timers met the +/- 10% deviation requirement. Although you stated that random sampling was to be performed periodically, these testing procedures were not in writing, random sampling was not based on a standardized sampling plan, and the test results were not documented. The timers were not evaluated prior to distribution of the tanning bed to the customer as is required by 21 CFR 1040.20(c)(2)(iii).
In addition, your firm failed to comply with requirements for reports and record keeping (Title 21 CFR 1002). 21 CFR 1002.13 requires that manufacturers submit annual reports to CDRH providing the volume of products produced, sold or installed. These reports are due annually by September 1 and shall cover the 12-month period ending on June 30 preceding the due date of the report.
Section 538(a) of the Act, Chapter V, Subchapter C Electronic Product Radiation Control prohibits any manufacturer from certifying or introducing into commerce sunlamp products which do not comply with the performance standard. It is also a prohibited act to fail to establish and maintain required records and to fail to submit required reports. Be advised that failure to respond to this letter may be considered to be a violation of section 538(a)(4) of the Act, 21 U.S.C. § 360(a)(4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. § 360pp. Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In order to address these violations you must:
1. Submit a complete description explaining how you will address the failure to test the tanning bed timers as is required by 21 CFR 1040.20(e)(2)(iii).
2. Submit annual reports covering all models of sunlamp products entered into commerce over the last 5 years in order to bring your annual reporting up-to-date as required by 21 CFR 1002.13. Annual reports must include any communications with customers, service personnel, dealers, distributors, or regulatory agencies that reference radiation safety or radiation emissions.
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 (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 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. 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 fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Florida District Office. Refer to the Unique Identification Number CMS case # 184052 when replying. If you have any questions about the content of this letter please contact: Carla A. Norris at 407-475-4730 or 407-475-4769.
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 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.
Acting Director, Florida District