Inspections, Compliance, Enforcement, and Criminal Investigations
American Mammographics Inc 3/16/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
March 16, 2009
WARNING LETTER NO. 2009-NOL-06
DELIVERY SIGNATURE REQUESTED
Adrian J. Palmer, President and Owner
American Mammographics, Inc.
5113 Highway 58, Suite 321
Chattanooga, Tennessee 37416-1669
Dear Ms. Palmer:
During an inspection of your firm, located in Chattanooga, Tennessee on September 17-19, 2008, an investigator from the United States Food and Drug Administration (FDA) determined your firm manufactures diagnostic x-ray mammography equipment, including S.O.F.T Paddles and the Mammospot platforms 1A and 1B. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code (USC) 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body.
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act, 21 USC 351(h), because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example, your firm has not established procedures for design controls.
2. Failure to establish and maintain procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm has not established procedures for purchasing controls which include the evaluation and selection of raw material suppliers and the establishment of specified purchasing data requirements for purchased or otherwise received product.
3. Failure to establish and maintain procedures for acceptance activities including inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). For example, [(b)(4)] does not adequately establish controls for the testing and release of finished devices because it requires final acceptance testing “up to [(b)(4)] of finished products” although you have indicated [(b)(4)] products are actually tested. Further, the procedure does not describe all in-process acceptance activities performed, including specified acceptance criteria.
4. Failure to establish and maintain procedures to control all quality system documents, as required by 21 CFR 820.40. For example, your firm has not established procedures for document control.
5. Failure to establish and maintain procedures for quality audits and have such audits conducted by individuals who do not have direct responsibility for the matters being audited, to assure the quality system is in compliance with the quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm has not established procedures for quality audits.
6. Failure to establish and maintain procedures for the documentation and validation or verification of design changes before their implementation, as required by 21 CFR 820.30(i). For example, changes to component specifications for the Mammospot 1B were not verified or validated before implementation.
The inspection revealed your firm’s devices are misbranded under Section 502(t)(2) of the Act, 21 USC 352(t)(2), because your firm failed or refused to furnish material or information respecting the device which is required by or under Section 519 of the Act, 21 USC 360i and 21 CFR 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
• Written MDR procedures have not been developed, maintained, and implemented, as required by 21 CFR 803.17. For example, your firm does not have MDR procedures in place to evaluate events to determine if it may be subject to MDR requirements.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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 money penalties. Also, federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
We are requesting you submit to this office, on the schedule below, certification by an outside expert consultant to state he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirements of the device Quality System regulation (21 CFR 820). You should submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) stating he or she has reviewed the consultant's report and your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certification of updated audits and corrections should be submitted to this office by the following dates:
• Initial certifications by consultant and establishment – July 1, 2009; and,
• Subsequent certification – January 30, 2010.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Finally, you should know this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Form FDA 483, Inspectional Observations, issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations to bring your products into compliance.
Your response should be sent to Cynthia R. Gibson, Compliance Officer, U.S. Food and Drug Administration, at the above address. If you have any questions about the content of this letter, please contact Ms. Gibson at (251) 344-8208, extension 105.
Carol S. Sanchez
Acting District Director
New Orleans District
Enclosure: Form FDA 483