Inspections, Compliance, Enforcement, and Criminal Investigations
Georgia Biomedical, Inc. 24-Jun-05
Department of Health and Human Services
Public Health Service
Atlanta District Office
June 24, 2005
VIA FEDERAL EXPRESS
Dr. Douglas E. Ott
Georgia Biomedical, Inc.
161 Gateway Drive, Suite B
Macon, GA 31210
Dear Dr. Ott:
During an inspection of your establishment located at 161 Gateway Drive, Macon, Georgia, from May 2 to 12, 2005, an investigator from the Food and Drug Administration (FDA) determined that your firm is a specifications developer and own label distributor of the CO2 Guard®, an insufflation tubing and filter assembly. This product is a device as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(h)].
The investigator documented significant violations of the Quality System Regulation (QSR), Title 21, Code of Federal Regulations (21 CFR), Part 820. These violations cause your device to be 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, its manufacture, packing, storage or installation are not in conformance with the applicable requirements for medical devices.
The following list includes, but is not limited to, the QSR deviations observed by the FDA investigator:
1. Management with executive responsibility has failed to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels, as required by 21 CFR 820.20.
There was a lack of management oversight of the responsible individuals involved with all aspects of the manufacturing and distribution of your device. You exhibited a lack of knowledge and familiarity with the quality processes and procedures in place for the manufacturing, sterilization, and various finished product examinations and releases applicable to your device. Furthermore, you have failed to ensure that the quality systems in place were adequate or effective and to maintain appropriate quality system records.
You have also failed to establish a policy of overall intentions and direction of your firm with respect to quality.
2. You have failed to establish and maintain procedures to ensure that all purchased products and services conform to specified requirements, as required by 21 CFR 820.50(a).
You have failed to define the type and extent of control to be exercised over the product, services, suppliers, and contractors used in the manufacture of your product. No formalized quality requirements have been established or documented for the contract manufacturers used to assemble and sterilize your product. Furthermore, you have not established any procedures for evaluating your suppliers and contract manufacture. No documentation was available of any evaluation of your assembler or the contract sterilizer utilized, to determine their ability to meet quality system requirements. You indicated that no such evaluation had been performed.
3. You have failed to establish and maintain adequate procedures to control changes to specifications, methods, and processes, as required by 21 CFR 820.70(b). The sterilization method was changed from ethylene oxide to gamma radiation. No documented verification was available that the change did not adversely affect the functionality of the product or the integrity of the packaging.
4. You have failed to establish complaint handling procedures sufficient to ensure that all complaints are documented and processed in a uniform and timely manner, as required by 21 CFR 820.198(a).
Although complaints have been received at your firm, no complaint handling procedures have been established These complaint handling procedures should ensure that the complaints are evaluated to determine if the complaint should be filed as a Medial Device Report under 21 CFR Part 803, as required by 21 CFR 820.198(d).
This letter is not intended to be an all inclusive list of the deficiencies at your facility. These violations may be symptomatic of serious underlying problems in your firm's quality assurance system. It is your responsibility to ensure adherence to each requirement of the Act and FDA regulations.
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 of your quality system. 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. Additionally, no premarket submissions for Class III devices to which QSR 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.
Please notify this office in. writing within fifteen (15) working days of receipt of this letter, of any steps that you are still in the process of taking to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) 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.
Your response should be sent to Philip S. Campbell, Compliance Officer, at the address noted in the letterhead. If you have any questions about this letter, you can contact Mr. Campbell at (404) 253-1280.
Mary H. Woleske
Director, Atlanta District
U.S. Food and Drug Administration