Inspections, Compliance, Enforcement, and Criminal Investigations
Agile Radiological Technologies, Inc. 17-Mar-06
Department of Health and Human Services
Public Health Service
Cincinnati District Office
VIA FEDERAL EXPRESS
March 17, 2006
Adel C. Chemaly, President
Agile Radiological Technologies, Inc.
11180 Reed Hartman Highway
Cincinnati, OH 45242-1829
Dear Mr. Chemaly:
The U.S. Food and Drug Administration (FDA) inspected your firm, Agile Radiological Technologies, Inc., Cincinnati, OH between January 17 and 27, 2006. During the inspection, the FDA investigator observed that your firm manufactures Radiation Analyzer (RAy) Film Dosimetry software. This product is a medical device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)).
The above stated inspection revealed that these medical devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S .C. § 351(h)), because the methods used in, or the facilities or controls used for their manufacturing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation for medical devices, as specified in Title 21, Code of Federal Regulations (C.F.R.), Part 820. Your firm's significant deviations from the QS regulation include, but are not limited to, the following:
Corrective and Preventive Actions
1. Failure to identify software errors ("bugs") as a data source for identifying existing and potential quality problems; and failure to document the investigation, the verification and/or validation of the corrective action, the implementation of the corrective action, and to assure that the corrective action taken is effective, as required by 21 C.F.R.§820.100(a). For example, the upgrade to version 2.0.7 on 7/21/04 stated that it fixed the following problem (bug): On attempting to click "print" in Export Handling, with no object selected to print, the system crashes.
This problem was not documented as a nonconformance; there was no failure investigation; and there was no verification/validation of the corrective action.
2. Failure to have complete procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 C.F.R. § 820.30(a). For example: The design control procedures in your Quality Manual do not:
Ensure all design input requirements (labeling, software requirements, etc.) relating to the device are identified and will appropriately address the intended use of the device.
Include a mechanism for addressing incomplete, ambiguous, and or conflicting requirements.
Ensure that the design outputs that are essential for the proper functioning of the device are identified.
Ensure that an individual, who did not have direct responsibility for the design stage being reviewed, be present during the design review.
3 . Failure to document, validate or where appropriate verify, review, and approve design changes, as required by 21 C.F.R. § 820.30(i) . Specifically, there have been 4 version updates and 5 "service pack" updates since the release of the "RAy Film Dosimetry Software in 2003. Your firm did not document the development, verification/validation, and review/approval of these changes.
4. Failure to establish and maintain a Design History File (DHF) for each type of device that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of 21 C.F.R. Part 820, as required by 21 C.F.R. § 820.30(j). For example, your firm has not demonstrated that the design of the Radiation Analyzer (RAy) Film Dosimetry Software was developed in accordance with the approved design plan and the design control requirements of the QS regulation.
Moreover, the design controls for the RAy Film Dosimetry Software are inadequate because of deficiencies including, but not limited to, the following: (1) a design plan identifying and describing interfaces with different groups or activities was not developed; (2) the design outputs that are essential for proper functioning of the software are not identified; (3) the verification testing for the case, export handling, toolbar and menu tests has not been performed to show that the design output meets the design input requirements; (4) a risk analysis for this software was not performed; (5) a formal document review of the design results has not been conducted and the results have not been documented; (6) your firm did not establish design validation procedures for this software to ensure design specifications conform with user needs and intended use(s) and (7) you did not document that the software was tested on a computer configured with the minimal specifications needed for the software to function. See 21 C.F.R. §§ 820.30(b), (c), (d), (e), (f), and (g).
Production and Process Controls
5. Failure to validate software used as part of the quality system, as required by 21 C.F.R. and track complaints on the RAy Film Dosimetry software has not been validated for its§ 820.70(i). Specifically, the [redacted] software your firm uses to document intended use according to established procedures.
6. Failure of management with executive responsibility to ensure that an effective quality system has been established and implemented, as required by 21 C.F.R. § 820.20. For example, your firm's quality system procedures for corrective and preventive action and design change control are incomplete; formal management review meetings which review the suitability and effectiveness of the quality system have not been conducted; and training procedures, that assure all personnel have been trained to adequately perform their assigned responsibilities have not been established.
7. Failure to establish adequate procedures for quality audits and to conduct such audits to assure that the QS is in compliance with the established QS requirements and to determine the effectiveness of the QS, as required by 21 C.F.R. § 820.22. Specifically, your firm has not conducted an audit; and the written audit procedure does not specifically state what areas will be audited, that the audit will be conducted by individuals who are not directly responsible for the matters being audited, and how reaudit of deficient matters will be conducted.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. The specific violations noted in this letter and in the List of Inspectional Observations (Form FDA 483), which was issued at the closeout of the inspection, may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. It is your responsibility to ensure that your firm complies with each requirement of the Act and FDA regulations.
Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Additionally, no requests for Certifications 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 violations. Failure to promptly correct these deviations may result in regulatory action being initiated by 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 after you receive this letter, of the specific steps you have taken or will take to correct the noted violations, including (1) the timeframes within which the corrections will be completed, (2) any documentation indicating that 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 ensure that similar violations will not recur.
Your written response to this Warning Letter should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679- 2700, extension 167, or you may forward a facsimile to her at (513) 679-2773.
Carol A. Heppe