From: Subject: All Medicus Co. Ltd., Warning Letter Date: Mon, 3 Mar 2008 11:22:27 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_00BE_01C87D20.DCC08890" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_00BE_01C87D20.DCC08890 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6578c.htm All Medicus = Co. Ltd., Warning Letter
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Department of Health and Human Services

Public Health Service
Food and Drug = Administration

 

2098 Gaither Road
Rockville MD = 20850


WARNING LETTER

VIA FEDERAL EXPRESS

AUG 29 2007

Mr. Gwan-Sik Kim
CEO and President
All Medicus Co. Ltd =
#7102=20 Dong-il Techno Town 7th
823 Gwanyang 2-dong
Anyang, Gyeonggi-do = 431-062=20
Korea

Dear Mr. Kim:

During an inspection of your firm located in Anyang, Gyeonggi-do, = Korea on=20 June 4, 2007 through June 7, 2007, investigator(s) from the United = States Food=20 and Drug Administration (FDA) determined that your firm manufactures = GlucoDr=99=20 super sensor and GlucoDr=99 super sensor Blood Glucose Test Strips. = Under section=20 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. = 321(h),=20 these products are devices because they are intended for use in the = diagnosis of=20 disease or other conditions or in the cure, mitigation, treatment, or = prevention=20 of disease, or are intended to affect the structure or function of the = body.=20

This inspection revealed that these devices are adulterated within = the=20 meaning of section 501(h) of the Act (21 U.S.C. =A7 351(h)), in that the = methods=20 used in, or the facilities or controls used for, their manufacture, = packing,=20 storage, or installation are not in conformity with the Current Good=20 Manufacturing Practice (CGMP) requirements of the Quality System (QS) = regulation=20 found at Title 21, Code of Federal Regulations = (C.F.R.), Part=20 820. We received a response from Mr. Je Young Chang, Senior Research = Engineer=20 dated June 18, 2007 concerning our investigator's observations noted on = the Form=20 FDA 483, List of Inspectional Observations that was issued to you, We = address=20 this response below, in relation to each of the noted violations. These=20 violations include, but are not limited to, the following:

1. Failure to establish and maintain adequate procedures for = validating the=20 device software design to conform to the intended uses, as required by = 21 CFR=20 820.30(g).
For example,

a. The validation results do not meet the pre-determined = acceptance=20 criteria, and there was no documentation why the results were=20 acceptable.

b. The validation reports do not contain an evaluation of the = validation=20 data and activities. Nor does it contain validation analyses and=20 conclusion.


We have reviewed your response and have concluded that it is = inadequate=20 because no information is provided other than the fact correction is = to be=20 taken by August 10th, 2007.

2. Failure to document acceptance activities, as required by 21 CFR = 820.80(c). For example,

a. Failure to document the acceptance status of the masks, by the = Quality=20 Assurance prior to release for use in production. Instead, they are = released=20 by verbal communication.

b. The suitability of vial labels released for use in packaging = area for=20 various customers is not documented.

We have reviewed your response and have concluded that it is = inadequate=20 because no information is provided other than the fact correction is = to be=20 taken by August 10th, 2007.

3. Failure to adequately document changes, as required by 21 CFR = 820.40(b).=20 For example, different LCD screen suppliers have different dimension=20 specifications. However, the [redacted] for LCD = change=20 history failed to include documentation of the change in the incoming=20 acceptance criteria on dimensions for each LCD supplier. It only = states the=20 change in the supplier. In addition, a clear set of LCD acceptance=20 specification documentation as supported by design validation is not = provided.=20

We have reviewed your response and have concluded that it is = inadequate,=20 because no information is provided other than the fact correction is = to be=20 taken by August 10th, 2007.

A follow up inspection will be required to assure that corrections = are=20 adequate. We will contact the appropriate people and request an = establishment=20 re-inspection. An FDA trip planner will be in touch with you to arrange = a=20 mutually convenient date for this inspection.

You should take prompt action to correct the violation(s) addressed = in this=20 letter. Failure to promptly correct these violation(s) may result in = regulatory=20 action, which may include detaining your devices without physical = examination=20 upon, entry into the United States until the corrections are completed. = Section=20 801(a) of the Act (21 U.S.C. =A7 381 (a)) Also, U.S. federal agencies = are advised=20 of the issuance of all Warning Letters about devices so that they may = take this=20 information into account when considering the award of contracts. = Additionally,=20 premarket approval applications for Class III devices to which the = Quality=20 System regulation deviations are reasonably related will not be approved = until=20 the violations have been corrected. Requests for Certificates to Foreign = Governments will not be granted until the violations related to the = subject=20 devices have been corrected.

Please notify this office in writing within fifteen (15) working days = from=20 the date you receive this letter of the specific steps you have taken to = correct=20 the noted violations, including an explanation of how you plan to = prevent these=20 violation(s), or similar violation(s), from occurring again. Include=20 documentation of the corrective action you have taken. If your planned=20 corrections will occur over time, please include a timetable for = implementation=20 of those corrections. If corrective action cannot he completed within 15 = working=20 days, state the reason for the delay and the time within which the = corrections=20 will be completed. If the documentation is not in English, please = provide a=20 translation to facilitate our review.

Your response should be sent to: James Woods (HFZ-440), 2098 Gaither = Road,=20 Rockville, MD 20850. If you have any questions about the content of this = letter=20 please contact: Tena Wei at 240-276-0393 (telephone) or 240-276-0644 = (fax).

Finally, you should know that this letter is not intended to be an=20 all-inclusive list of the violation(s) at your facility. It is your=20 responsibility to ensure compliance with applicable laws and regulations = administered by FDA. The specific violation(s) noted in this letter and = in the=20 Inspectional Observations, Form FDA 483 (FDA 483), issued at the = closeout of the=20 inspection may be symptomatic of serious problems in your firm's = manufacturing=20 and quality assurance systems. You should investigate and determine the = causes=20 of the violation(s), and take prompt actions to correct the violation(s) = and to=20 bring your products into compliance.

Sincerely yours,

/S/

Steven I. Gutman, M.D., M.B.A.
Director
Office of in Vitro = Diagnostic=20 Device
Evaluation and Safety
Center for Devices and Radiological = Health=20

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