Inspections, Compliance, Enforcement, and Criminal Investigations
Defibtech, LLC 4/24/07
Department of Health and Human Services
|Public Health Service |
Food and Drug Administration
|New England District |
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
VIA FEDERAL EXPRESS
April 24, 2007
Gintaras Vaisnys, President
741 Boston Post Road, Suite 201
Guilford, Connecticut 06437
Dear Mr. Vaisnys:
During an inspection of your firm located in Guilford, Connecticut on March 5 through 15, 2007 an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures automated external defibrillators (AED's). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 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 are intended to affect the structure or function of the body.
This inspection revealed that these devices are 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, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1) Failure of your design validation to ensure that your devices conform to defined user needs and intended uses and to include testing under actual or simulated use conditions (21 CFR 820.30(g)). For example,
a) The AEDs self diagnostic testing software failed to operate as intended. In three (3) separate instances the AEDs went through the scheduled quarterly internal diagnostic self test that determines if there is sufficient energy in the battery to deliver a [redacted] and determined there was insufficient energy to deliver a [redacted] The AEDs then alert the users of the "low battery" status with an audible warning and a flashing red light warning to indicate to the user the AEDs were not suitable for use. The AEDs should have remained in "low battery" status. The "low battery" status in each of these three AEDs were then incorrectly overridden to the "ready" status when AED's went through self diagnostic tests that only determined if the batteries were alive. All three AEDs were then connected to patients in real life saving emergencies and "shut down" because of "low battery."
b) The AED's battery packs were not validated under actual or standby conditions. For example, there is no validation program currently in place or validation data available which monitors or documents the devices under actual or standby conditions.
2) Failure to establish and maintain procedures for implementing corrective and preventative action and to document all activities under this section and their results (21 CFR 820.100(a) and (b)). For example, CAR 04-008 initiated on 5/12/2003 and closed on 1/31/2005, stated that unit testing was to be performed which included a [redacted] This was not available during the inspection to demonstrate that this testing was conducted on the affected units.
3) Failure to establish and maintain procedures for implementing corrective and preventative action that includes implementing appropriate statistical methodology be employed where necessary to detect recurring quality problems (21 CFR820.100(a)(1)). For example, in CAR 04-008 your risk analysis included the number of AEDs that were sold for use, as [redacted] There was no documentation available during the inspection to demonstrate the number of actual units sold by your firm that had [redacted] transformers.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 money penalties. Also, 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, 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 received your response to the FDA 483 on April 4, 2007 from Dr. Laub which describes your proposed corrective actions. In your response to this Warning Letter please provide documentation of the validation that was performed, as well as the revised SOPs. Your response should also include steps you have taken to prevent these issues from recurring.
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 violation(s), or similar violation(s), 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.
Your response should be sent to: Bruce R. Ota, Food and Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact: Mr. Ota at 781-596-7762.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), 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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
New England District
cc: Dr. Glen Laub, CEO
741 Boston Post Road
Guilford, Connecticut 06437