Inspections, Compliance, Enforcement, and Criminal Investigations
Total Medical Inofrmation Management Systems, Inc. 07-Sep-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
555 Winderley Place Suite 200
Maitland, FL 32751
September 7, 2001
Donald S. Beavers, President
Total Medical Information Management Systems, Inc.
407 Wekiva Springs Road
Longwood, Florida 32779
Dear Mr. Beavers:
During an inspection of your establishment located in Longwood, Florida on August 6-7, 2001, FDA Investigator Ronald T. Weber determined that your establishment is a manufacturer and distributor of picture archiving and communication systems software, which is a medical device as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
Under the Federal Food, Drug, and Cosmetic Act (the Act), the product that your firm manufactures is considered to be a medical device that is used to diagnose or treat medical conditions or to affect the structure or function of the body. The law requires that manufacturers conform to the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820.
The above-stated inspection revealed that the device is 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 for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Your firm?s management with executive responsibility failed to ensure that an adequate and effective quality system has been fully established and maintained, as required by 21 CFR 820.20. For example, a quality system has not been established including, but not limited to, quality audits, design controls, document controls, purchasing controls, production and process controls, nonconforming product, corrective and preventive action, installation, records and complaint files (FDA 483, Item #1).
2. Your firm failed 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. For example, the software designed by your firm was developed without design controls (FDA 483, Item #2).
The specific violations noted in this letter and in the List of Observations (FDA 483) issued to you at the closeout 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. If the causes are determined to be systems problems, you must promptly initiate permanent corrective actions.
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 Ill devices to which QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates for Products for Export 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 penalties.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of any steps you may have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed if different from those annotated on the FDA 483, (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 Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.Sincerely,
Director, Florida District