self fabricated prosthesis
Ingvar Leskovar
Description
Collection
Title:
self fabricated prosthesis
Creator:
Ingvar Leskovar
Date:
11/3/2010
Text:
I guess, like most of us, I had few laughs over the Colonel's leg ad.
But then again, it may be a much more serious business, with dem legs
making, than we generally are used to. Though FDA considers prosthetic
componentry and controls (not sure, where do sockets fall in this category)
a Category I devices, and, as such, does not really regulate them, there is
a strong push towards changing this.
Also, how serious it can get, judge from the letter below(I have removed all
names and addresses)
I. Lesko, CPO
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
August 30, 2005
W/L 18-05
John Doe
President
********* Prosthetics Orthotics, Inc.
**** **** Blvd., Suite ###
Los Angeles, CA
Dear Mr. Doe
During an inspection of your firm located in Los Angeles, California, on
March 1, 2005 through March 11, 2005, and a follow-up visit on May 19, 2005
to collect additional information, our investigator(s) determined that your
firm manufactures several external assembly lower limb prostheses, limb
orthoses and truncal orthoses. These products are devices within the meaning
of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21
U.S.C. § 321(h)), because they are intended to affect the structure or any
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.
Significant violations include, but are not limited to, the following:
1. Failure to establish, maintain and control a quality system that is
appropriate for specific devices manufactured, as required by 21 CFR §
820.20. For example,
You do not have established procedures for conducting management reviews,
and the dates of management reviews are not documented, as required by 21
CFR § 820.20(c).
The management representative has not ensured that quality system
requirements are effectively established and maintained, as required by 21
CFR § 820.20(b)(3)(i). Specifically, you have not established procedures for
complaint handling, management review, nonconforming product and document
control.
2. Failure to establish procedures for conducting quality audits, and
failure to conduct audits to verify that the quality system is effective in
fulfilling the quality system objectives, as required by 21 CFR § 820.22.
Specifically, you have not established a quality audit procedure and have
not conducted quality audits to verify your quality system is effective.
3. Failure to establish and implement procedures for receiving, reviewing
and evaluating complaints by a formally designated unit to ensure that all
complaints are processed in a uniform and timely manner and failure to
maintain complaint files, as required by 21 CFR § 820.198(a). Specifically,
your complaint handling procedure does not include a procedure for analysis,
response, and corrective action after receipt of a complaint. Furthermore,
your **** ***** Prosthetics Orthotics, Inc Handbook states, under
Communication/Complaint Handling, that any complaint received shall be
written on a grievance form and given to the President/CPO within 24 hours.
However, the complaint procedure does not specify any follow-up to the
complaint. In addition, complete complaint files are not maintained at a
central location but were found in different locations.
4. Failure to establish and maintain procedures to control product that does
not conform to specified requirements, as required by 21 CFR § 820.90(a).
Specifically, you do not have an established procedure in place for handling
nonconforming components and nonconforming finished products.
5 . Failure to establish and implement procedures for document control, as
required by 21 CFR § 820.40. Specifically, you have no document control
procedure to ensure that only accurate and current versions of documents are
used and that obsolete documents are not used.
In addition, your external assembly lower limb prostheses; limb orthoses and
truncal orthoses are misbranded under Section 502(b) (21 U.S.C. 352(b)) in
that the devices in package form do not bear a label containing : (1) the
name and place of business of the manufacturer, packer, or distributor and
(2) an accurate statement of the quantity of the contents in tenns of
weight, measure, or numerical count.
Finally, we received an annual registration on March 22, 2005, advising us
that your facility is no longer a device establishment. However, the
products identified above are devices and, consequently, your firm is
required to register the facility, as well as list these devices, even
though they do not require the submission of a premarket notification .
Because your firm no longer has a valid registration, you will need to
complete and submit forms FDA 2891, Registration of Device Establishment and
FDA 2892, Device Listing, available at
<URL Redacted>< <URL Redacted>>
This letter is not intended to be an all-inclusive list of deficiencies at
your facility. It is your responsibility to ensure adherence to each
requirement of the Act and regulations.
The specific violations noted in this letter and on the Form FDA-483 issued
at the conclusion of the inspection may be symptomatic of serious underlying
problems in your establishment's quality system. You are responsible for
investigating and determining the causes of the violations found by the FDA.
You also must promptly initiate permanent corrective and preventive action
for 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 approval applications
(PMAs) for Class III devices to which the Quality System/GMP deficiencies
are reasonably related will be approved until the violations have been
corrected. Also, no requests for certificates to foreign governments will be
granted until the violations related to the subject devices have been
corrected.
You should take prompt action to correct the violations cited in this
letter. Failure to promptly correct these deviations may result in
regulatory action without further notice. These actions include, but are not
limited to, seizure, injunction, and/or civil penalties.
Please notify this office within 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 identify and make
corrections to any underlying systems problems necessary to assure that
similar violations will not recur. 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 implemented.
If you have any questions regarding this letter, please contact Mariza M.
Jafary, Compliance Officer at 949-608-2977.
Your written reply should be addressed to:
Pamela B. Schweikert
Director, Compliance Branch
U.S . Food and Drug Administration
19701 Faiorchild
Irvine, CA 92612-2446
Sincerely,
/s/
Pamela Schweichert for Alonza E. Cruse
--
One cannot always be a hero, but one can always be a human. - Goethe
But then again, it may be a much more serious business, with dem legs
making, than we generally are used to. Though FDA considers prosthetic
componentry and controls (not sure, where do sockets fall in this category)
a Category I devices, and, as such, does not really regulate them, there is
a strong push towards changing this.
Also, how serious it can get, judge from the letter below(I have removed all
names and addresses)
I. Lesko, CPO
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
August 30, 2005
W/L 18-05
John Doe
President
********* Prosthetics Orthotics, Inc.
**** **** Blvd., Suite ###
Los Angeles, CA
Dear Mr. Doe
During an inspection of your firm located in Los Angeles, California, on
March 1, 2005 through March 11, 2005, and a follow-up visit on May 19, 2005
to collect additional information, our investigator(s) determined that your
firm manufactures several external assembly lower limb prostheses, limb
orthoses and truncal orthoses. These products are devices within the meaning
of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21
U.S.C. § 321(h)), because they are intended to affect the structure or any
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.
Significant violations include, but are not limited to, the following:
1. Failure to establish, maintain and control a quality system that is
appropriate for specific devices manufactured, as required by 21 CFR §
820.20. For example,
You do not have established procedures for conducting management reviews,
and the dates of management reviews are not documented, as required by 21
CFR § 820.20(c).
The management representative has not ensured that quality system
requirements are effectively established and maintained, as required by 21
CFR § 820.20(b)(3)(i). Specifically, you have not established procedures for
complaint handling, management review, nonconforming product and document
control.
2. Failure to establish procedures for conducting quality audits, and
failure to conduct audits to verify that the quality system is effective in
fulfilling the quality system objectives, as required by 21 CFR § 820.22.
Specifically, you have not established a quality audit procedure and have
not conducted quality audits to verify your quality system is effective.
3. Failure to establish and implement procedures for receiving, reviewing
and evaluating complaints by a formally designated unit to ensure that all
complaints are processed in a uniform and timely manner and failure to
maintain complaint files, as required by 21 CFR § 820.198(a). Specifically,
your complaint handling procedure does not include a procedure for analysis,
response, and corrective action after receipt of a complaint. Furthermore,
your **** ***** Prosthetics Orthotics, Inc Handbook states, under
Communication/Complaint Handling, that any complaint received shall be
written on a grievance form and given to the President/CPO within 24 hours.
However, the complaint procedure does not specify any follow-up to the
complaint. In addition, complete complaint files are not maintained at a
central location but were found in different locations.
4. Failure to establish and maintain procedures to control product that does
not conform to specified requirements, as required by 21 CFR § 820.90(a).
Specifically, you do not have an established procedure in place for handling
nonconforming components and nonconforming finished products.
5 . Failure to establish and implement procedures for document control, as
required by 21 CFR § 820.40. Specifically, you have no document control
procedure to ensure that only accurate and current versions of documents are
used and that obsolete documents are not used.
In addition, your external assembly lower limb prostheses; limb orthoses and
truncal orthoses are misbranded under Section 502(b) (21 U.S.C. 352(b)) in
that the devices in package form do not bear a label containing : (1) the
name and place of business of the manufacturer, packer, or distributor and
(2) an accurate statement of the quantity of the contents in tenns of
weight, measure, or numerical count.
Finally, we received an annual registration on March 22, 2005, advising us
that your facility is no longer a device establishment. However, the
products identified above are devices and, consequently, your firm is
required to register the facility, as well as list these devices, even
though they do not require the submission of a premarket notification .
Because your firm no longer has a valid registration, you will need to
complete and submit forms FDA 2891, Registration of Device Establishment and
FDA 2892, Device Listing, available at
<URL Redacted>< <URL Redacted>>
This letter is not intended to be an all-inclusive list of deficiencies at
your facility. It is your responsibility to ensure adherence to each
requirement of the Act and regulations.
The specific violations noted in this letter and on the Form FDA-483 issued
at the conclusion of the inspection may be symptomatic of serious underlying
problems in your establishment's quality system. You are responsible for
investigating and determining the causes of the violations found by the FDA.
You also must promptly initiate permanent corrective and preventive action
for 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 approval applications
(PMAs) for Class III devices to which the Quality System/GMP deficiencies
are reasonably related will be approved until the violations have been
corrected. Also, no requests for certificates to foreign governments will be
granted until the violations related to the subject devices have been
corrected.
You should take prompt action to correct the violations cited in this
letter. Failure to promptly correct these deviations may result in
regulatory action without further notice. These actions include, but are not
limited to, seizure, injunction, and/or civil penalties.
Please notify this office within 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 identify and make
corrections to any underlying systems problems necessary to assure that
similar violations will not recur. 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 implemented.
If you have any questions regarding this letter, please contact Mariza M.
Jafary, Compliance Officer at 949-608-2977.
Your written reply should be addressed to:
Pamela B. Schweikert
Director, Compliance Branch
U.S . Food and Drug Administration
19701 Faiorchild
Irvine, CA 92612-2446
Sincerely,
/s/
Pamela Schweichert for Alonza E. Cruse
--
One cannot always be a hero, but one can always be a human. - Goethe
Citation
Ingvar Leskovar, “self fabricated prosthesis,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 2, 2024, https://library.drfop.org/items/show/232049.
