Daavlin and Amjo 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
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 Therapeutic 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/products.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
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 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
Food and Drug Administration
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
VIA FEDERAL EXPRESS
September 22, 2004
Mr. David W. Swanson, president
Daavlin Distribution Company
205 West Bement Street
Bryan, Ohio 43506-0626
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
labelling, 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
wilfully 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:
(a) Model No. Spectra 305/350;
(b) Model No. Spectra 350;
(c) Model No. Spectra 305;
(d) Model No. Spectra Mini. Recall #Z-490/493-1.
Code: Serial numbers: Undetermined.
Manufacturer: The Daavlin Distributing Company, Bryan, Ohio.
Recalled by: Manufacturer. FDA approved the firm's
corrective
action plan February 28, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 421 units.
Reason: The units failed to terminate radiation exposure
after
a pre-set dosage/time causing unnecessary exposures to
ultraviolet radiation.
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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