Inspections, Compliance, Enforcement, and Criminal Investigations
Odyssey Medical Inc. 04-Dec-03
Department of Health and Human Services
Public Health Service
New Orleans District
December 4, 2003
VIA FEDERAL EXPRESS
Gary A. Tatge, President
Odyssey Medical Inc.
5828 Shelby Oaks Drive
Memphis, Tennessee 38134-7315
Warning Letter No. 2004-NOL-07
Dear Mr. Tatge:
During an inspection of your establishment on October 20-24, 2003, our investigator
determined that you manufacture Punctal Occluders. These products are devices
as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic: Act (the
The above-stated inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System Regulation (QSR) for medical devices as specified in Title 21, Code of Regulations (CFR), Part 820.
The inspection revealed an inadequate quality control system [21 CFR 820.20],
inadequate quality audits [21 CFR 820.22], inadequate training of firm personnel
[21 CFR 820.25], inadequate process validation [21 CFR 820.75], incomplete receiving
and inspection reports [21 CFR 820.80(b) & (e)]. incomplete and inadequate
corrective and preventive action procedures [21 CFR 820.100(b)], inadequate
device master records [21 CFR 820. 181(b) & (c)], and inadequate complaint
procedures [21 CFR 820.198].
This letter is not intended to be an all-inclusive list of deficiencies at
your facility. It is your responsibility to ensure adherence to eat h requirement
of the Act and regulations. The specific violations noted in this letter and
the Form FDA 483 issued at the conclusion of the inspection may be symptomatic
of serious underlying problems in your establishments Quality System.
You are responsible for investigating and determining the cause of the violations
identified by the U.S. Food and Drug Administration (FDA).
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 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
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 begin taken to identify and make corrections to any underlying system problems necessary to assure that similar violations will not occur.
If corrective action cannot be completed within fifteen (15) working days,
please state the reason for the delay and the time within which the corrections
will be completed. Your reply should be directed to the attention of Joseph
E, Hayes, Compliance Officer, U.S. Food and Drug Administration, 297 Plus Park
Boulevard, Nashville, Tennessee 37217.
Patricia K. Schafer
Acting Director, New Orleans District