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| Daavlin and Amjo Guilty of Anti-Competitive Behaviour
Daavlin USA continually criticise their legitimate competitors and highlight their "financial loss" caused by their competitors, yet blatantly ship their own products worldwide with no regard for local laws or medical regulations, yes, we have documented evidence of this.
It is the policy of Beat Psoriasis to never engage in proactive defamatory, insulting or anti-competitive behaviour. Healthy competition results in better prices and higher levels of support for the end users, we welcome competitors. Competition ensures that the consumer (e.g. you receive best pricing and best support available.) However, due to recent unhealthy encounters with our competitors, the need has arisen to refute some anti-competitive propaganda. It greatly saddens us that our competitors are wasting their energy on such negative practices. We openly encourage you to shop around before selecting a supplier for your UV phototherapy products. Eventually most people can see through the "hype" and select a supplier who can personally relate with their own experiences, has a strong track record of providing excellent service, best possible pricing and fastest delivery in the industry. You need to be familiar with the firm's track record, the people involved and the ethics displayed by each firm. It is important to note that the owners of Beat Psoriasis suffer from psoriasis themselves and have a real and genuine vested interest in marketing, supplying and supporting quality UV phototherapy products. Unlike our competitors who either drop ship from another location (adding no value) or are openly motivated by financial gain only.
Chris Cane Amjo extract from the Psoriasis Hall of Shame
Chris Cane, another UV lamp salesman has also been hawking his wares in the support newsgroups. His first attempt was healthytan dot com which must be considered an oxymoron, since tanning is not healthy for the skin. In setting up a web site to target psoriatics, he first chose the name puvb dot com thinking that the P in PUVA stands for psoriasis rather than psoralen. Once this was pointed out, he changed the name of the site and now presents as "facts" a long list of inaccurate and misleading claims about the newer narrowband UVB phototherapy bulbs now available. As long as Amjo continues to promote prescription products this way, please take your business to any other supplier. Since Amjo is a main marketer of Daavlin products, a letter of protest to Daavlin may be one way to voice disapproval of these tactics. (source Psoriasis Hall of Shame.) [top of page]
Anticompetitive complaint from Daavlin - Part 1 of 3.
On April 1, 2005 (was this an April fool's joke?) David W. Swanson from Daavlin Corp USA sent the following letter to the Australian Therapeutic Goods Administration, our equivalent of the FDA. Unfortunately David W. Swanson at Daavlin Corp seems blatantly more interested in his financial income than providing a quality product or services. All correspondence from Daavlin Corp clearly states money as a motivating factor for their decisions. Please see the Australian Therapeudic Goods Administration own web page here; http://www.tgacc.com.au/complaintsList.cfm complaint "16/06/05 14-0405" stating the complaint from Daavlin USA regarding beatpsoriasis.com's advertising is "not justified."
April 1, 2005. The Executive Officer Complaints Resolution Panel
Dear Sir or Madam,
We are a US manufacturer of ultraviolet phototherapy devices that are used for the treatment of psoriasis and vitiligo. We market these devices throughout the United States and the world (comment: Daavlin devices largely do NOT have CE Approval or international approvals for worldwide sales!) Federal Law in the United States requires that these class IIa devices be sold under prescription from a licensed physician.
Enclosed are pages from a WEB site located at www.beatpsoriasis.com/pricelist.htm (is this a breach of copyright?) You will note that on page three of the enclosed copy of the WEB page, they state that no prescription is necessary, even in Great Britain and the United States. This is blatantly untrue.
We have contacted the United States Food and Drug Administration about this issue but they can only interdict these devices at the border which is problematic. The best solution, is to require this company to discontinue selling these class IIa medical devices without a a prescription and to discontinue advertising them as not requiring a prescription.
We are concerned about the dangers of patients obtaining medical products with which they could hurt themselves and we are of course also convened about the competitive disadvantages to which we are put when we obey the law and this company does not. (See our own evidence following that Daavlin blatantly and hypocritically break the same laws they have falsely accused beatpsoriasis of doing.)
Please do not hesitate to contact us should you have questions or need anything further from us.
Signed David W. Swanson, President of Daavlin Corp (original available on request.) [top of page]
Our response to the Daavlin complaint - Part 2 of 3
As Daavlin's complaint was not even sent to use directly, we were forced to respond via the complaints resolution panel at the TGA. We did so immediately in writing that can be summarised as follows (as the letter was 27 pages including FDA and TGA evidence
"Any finding by the complaints panel will be upheld" "A prescription for phototherapy equipment is only required if purchasing domestically within the USA, NO PRESCRIPTION is required if importing as a US/FDA customs declaration supersedes the requirement for a prescription." "No prescription is required in Britain for purchase or sale of phototherapy equipment, this comment by Daavlin Corp is completely false and misleading, therefore the original statement by Beatpsoriasis.com is correct. This has been confirmed by the UK NHS Health Department in writing." "Daavlin are obviously acting unethically and financially motivated" "Daavlin themselves export unapproved products" "It is only illegal to import unapproved products" "All products that beatpsoriasis.com supply are FDA approved" "The FDA has contacted us directly and has no problem with our advertising" "As stated in the Complaints Resolution procedures, Daavlin Corp have made no attempt to contact us directly to seek a resolution prior to making a formal complaint." "We have own own documented evidence of ongoing unethical practices by Daavlin Corp and particularly David W. Swanson." [top of page]
Conclusion to Daavlin Complaint - Part 3 of 3
A ruling has been made on this matter in favour of beatpsoriasis.com's claims. An extract of the determination letter is included here;
The Managing Director Beatpsoriasis.com
Complains Resolution Panel Determination
The complaint.
1. On 7 April 2005, the Complaints Resolution Panel ("the panel") received a written complaint in relation to the web site www.beatpsoriasis.com, which was promoting the range of Dermalight Phototherapy UV Lamps.
2. The USA based complainant, Daavlin, alleged that the claim "customers (including American and British) do not require a doctor's prescription to purchase from us" is untrue. The complainant also stated "federal law in the United States requires that these class IIa devices be sold only under prescription from a licensed physician."
3. On 29 April 2005, the Executive Officer referred the complaint to the sponsor "beatpsoriasis.com" ("the respondent"), inviting a response to the concerns raised by the complainant.
4. By way of an undated letter (received 2 May 2005), the respondent indicated a willingness to comply with any findings of the Panel and that the claim in question had been removed from the website, pending resolution of this matter.
5. The respondent also denied the basis of the complaint advising as follows
a. The US Food and Drug Administration (FDA) "has found nothing wrong with our advertising";
c. "we have independent information from the FDA that a prescription is only required if purchasing domestically within the USA."
Panel Consideration
6. Complaints about Internet advertisements to consumers for therapeutic goods are within the jurisdiction of the Panel, since the internet falls within the definition of "specified media."
7. The Panel notes that clauses of 4.1.1(b) and 4.1.2(c) Of the Therapeutic Goods Advertising Code require that advertisements for therapeutic goods contain correct and balanced statements and must not mislead directly or by implication.
8. The Panel accepted the respondent's advice that a doctor's prescription is required only where the product is purchased within the USA...
9. The Panel was of the view that the USA legal requirement would not apply where a US patient purchased the product directly from the Western Australian based sponsor (beatpsoriasis.com) via the internet. It would be the US patient's responsibility to ensure that any US "personal importation" requirements were satisfied prior to completing the transaction. On the material before the Panel, these importation requirements did not include a prescription.
10. Accordingly, the Panel considered that the statement on the sponsor's website i.e. "customers (including American and British) do not require a doctor's prescription to purchase from us" is true. The Panel therefore found the complaint (by Daavlin Corp) to be unjustified.
11. However, in the interests of clarity, the Panel did consider that the wording of the statement could be improved etc.... [top of page]
Daavlin: FDA warning letter to Daavlin USA
Public Health Service VIA FEDERAL EXPRESS
September 22, 2004 Mr. David W. Swanson, president Warning Letter CIN-04-22469
Dear Mr. Swanson,
During an inspection of your establishment (The Daavlin Company) located in Bryan, Ohio, on June 14-18, 2004, our Investigator determined that your firm manufactures various phototherapy units used to treat skin conditions such as psoriasis, vitiligo, and eczema. Your phototherapy units are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The above-stated inspection revealed that these devices (manufactured by Daavlin) are adulterated under section 501 (h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing practice (CGMp) requirements for medical devices which are set forth in the Quality System regulations, as specified in Title 21, Code of Federal Regulations (CFR), part 820. Significant deviations include, but are not limited to, the following:
1. Failure to establish a quality plan, as required by 21 CFR 820.20(d). For example, a written quality plan that defines the quality practices and the resources and activities relevant to the devices being manufactured has not been implemented.
2. Failure to establish procedures for management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency, as required by 21 CFR 820.20(c). For example, there are no written procedures defining management reviews to include the frequency of the review meetings.
3. Failure to 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, as required by 21 CFR 820.22. For example, there are no written procedures defining quality audits to include formal planned checks of all elements of the quality system. Also, you have not conducted any quality audits to determine the effectiveness of the quality system.
4. Failure of management with executive responsibility to appoint, and document such appointment of, a member of management who shall ensure that quality system requirements are effectively established and effectively maintained in accordance with this part and report on the performance of the quality system to management with executive responsibility for review, as required by 21 CFR 820.20(b)(3). For example, no management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
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(a). For example, the Dermapal and the 3 Series Full Body phototherapy Device were recent design projects that were developed into marketed devices. There was no design control process established or implemented detailing the design requirements such as documentation of design inputs, design outputs, verification, validation, design review, and design transfer.
6. Failure to 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). For example, design changes made to the 3 Series Full Body phototherapy Device software to correct design defects were conducted without controlling the design process.
7. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, corrective and preventive action procedures have not been implemented.
8. Failure to establish and implement procedures to verify and validate corrective and preventive action to ensure that such action is effective and does not adversely affect the finished product, as required by 21 CFR 820.100(a)(4). For example, corrective actions taken regarding updating the software provided with the 3 Series Full Body phototherapy device were not fully verified and validated.
9. Failure to document all activities required under this section, and their results, as required by 21 CFR 820.100(b). There was no documentation to demonstrate that the software changes implemented with the 3 Series Full Body phototherapy Device performed as intended. Also, there was no documentation to show that changes made to the software do not adversely affect the finished device.
10. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, there is no written complaint handling procedure that has been implemented that defines receipt of complaints ad their evaluation by a formally designated unit.
11. Failure to maintain device master records (DMR’s), as required by 21 CFR 820.181. For example, there are no established and implemented DMR’s for any of the medical devices manufactured, which includes the 3 Series Full Body phototherapy Device, the Spectra Series of phototherapy devices, and Dermapal.
12. Failure to establish and ,maintain procedures to ensure that the device history records (DHR’S) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184. For example, there are no established and implemented DHR’s for any of the medical devices manufactured, which include the 3 Series Full Body phototherapy Device, the Spectra Series of phototherapy devices, and Dermapal.
13. 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). For example, process control procedures for the 3 Series Full Body phototherapy Device, the Spectra Series of phototherapy devices, and Dermapal have not been implemented. Also, the procedures are not signed and approved by management and QA.
14. Failure to establish procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, there are no written procedures identifying the training necessary to adequately perform their assigned responsibilities.
Additionally, the above-stated inspection revealed that you distributed at least six (6) 3 Series Full Body phototherapy Devices with Smart Touch Control Systems (a class II phototherapy device) domestically and an additional seven (7) devices to foreign consignees without complying with 510(k) of the Act. In a letter dated March 1, 2004, The Office of Device Evaluation (ODE), Center for Device and Radiological Health (CDRH) responded to your February 5, 2004 letter, titled “Model Change Report,” informing you that because of the information that you provided to ODE it appeared that you significantly changed or modified the design, components, methods of manufacture, device labeling, or intended use of the device and that therefore you needed to submit a new 510(k) for that device. During the inspection you told the investigator that you willfully sold these unapproved devices because you did not want to lose potential sales.
In legal terms, the 3 Series Full Body phototherapy Device with Smart Touch Control System is adulterated under section 501(f)(1)(B) in that it is a class III device under section 513(f) and does not have an approved application for premarket approval in effect pursuant to section 515(a) or an approved application for an investigational device exemption under 520(g). Your 3 Series Full Body phototherapy Device with Smart Touch Control System is also misbranded under section 502(o) because a notice or other information respecting the device was not provided to the FDA as required by section 510(k) and 21 CFR 807.81 (a)(3)(i).
Further, the above-stated inspection revealed that your devices are misbranded under section 502(t)(2) of the Act, in that your firm failed or refused to furnish any material or information required by or under section 519 respecting the device and 21 CFR part 803 (Medical Device Reporting) regulation. Specifically, there is no written MDR procedure detailing timely and effective identification of events, the standardized review process, ensuring timely transmission of MDR’s, and ensuring record keeping requirements are met, as required by 21 CFR 803.17.
This letter is not intended to be an all-inclusive list of deficiencies at your facility (The Daavlin Company.) It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm’s manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.
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, no premarket submissions for Class III devices to which the Quality System regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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.
We acknowledge the receipt of your letter dated July 6, 2004, responding to the FDA 483 Inspectional Observations that our Investigator issued. Please note that your letter does not address any specific timeframes for when you will accomplish your corrective actions; therefore, your response is inadequate.
please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. 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.
Your response should be sent to Compliance Officer, Food and Drug Administration.
* This text regarding Daavlin Corp has been produced by the FDA, it is included for informational purposes only and is provided strictly "without prejudice." [top of page]
FDA's original findings of 421 faulty Daavlin products
Product: Phototheraphy devices:
Continuing deceitful practices by Daavlin Corp
In the next few days we will including uncontroversial evidence that Daavlin are guilty of the very claims they make against their competitors and ongoing anti-competitive behaviour. Furthermore, we know for a fact that Daavlin export their products to numerous countries where they have no medical approvals for their products.
Do Daavlin and Amjo Corp supply medical devices to locations in the world contrary to local laws and regulations - YES THEY DO.
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Home UV phototherapy for psoriasis, vitiligo, dermatitis, hyperhidrosis, acne and laser therapy for hair loss.