Inspections, Compliance, Enforcement, and Criminal Investigations
LifeCare Technologies, Inc. 4/2/07
Department of Health and Human Services
|Public Health Service |
Food and Drug Administration
555 Winderley Pl., Ste. 200
CERTIFIED MAIL - FACSIMILE
RETURN RECEIPT REQUESTED
April 2, 2007
Mr. Kulwant S. Grewal
Vice President & Chief Operating Officer
LifeCare Technologies, Inc.
4710 Eisenhower Blvd, Ste. A-10
Tampa, Florida 33634-6308
Dear Mr. Grewal:
During an inspection of your firm located in Tampa, Florida, on August 21 through August 23, 2006, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Perinatal Information Network (P.I.N.) software. Under section201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these productsare 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 (CFR), Part 820. We received two responses from Mr. Gary L. Nesbitt dated September 11, 2006 and October 23, 2006, concerning our investigator's observations noted on the Form FDA 483, that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures that ensure design validation to include software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g). For example:
a. The firm failed to document structural (white box) testing of its P.I.N. software, including independent code reviews, and the firm lacks documentation of validation of its compiler.
We have reviewed your response and have concluded that it is inadequate because you have yet to provide any supporting documentation for the corrections, corrective actions, or any preventive actions.
2. Failure to establish and maintain procedures for the documentation of design changes before their implementation, as required by 21 CFR 820.30(i). For example, the firm lacks documentation of the reasoning for all significant changes to P.I.N. software since 1990.
We have reviewed your response and have concluded that it is inadequate because you need to provide supporting documentation for the corrections, corrective actions, or any preventive actions. While you have addressed design inputs, you have not addressed design changes. Documentation needs to be submitted for the identification, validation, or where appropriate, verification, review and approval of all design changes to the PIN software.
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, which include requirements for investigating the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2). For exatnple, the firm received at least 16 complaints in 2006 concerning signal and/or data being lost at the Central "Station or Bedside Monitor related to the P.I.N. software and failed to document the potential root cause of the problem.
We have reviewed your response and have concluded that it is inadequate because you have yet to provide any supporting documentation for this corrective action.
4. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, which include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820. 1 00(a)(4). For example, the firm's corrective and preventive action procedure lacks a requirement for all corrective and preventive actions to be verified and/or validated as effective and that all corrective and preventive actions will not adversely affect the finished device.
We have reviewed your response and have concluded that it is inadequate because the corrective action involved revising the Corrective and Preventive Action Procedure, SOP 04004, to clarify that all Corrective and Preventive Actions (CAPAs) will be verified and/or validated as effective, and that they will not adversely affect the finished device. In addition, you have not provided any evidence that you trained your employees on the revised SOP and that you have implemented the revised SOP Further, you should provide information about the steps you have taken to evaluate recent CAPAs to ensure their effectiveness according to the new procedure.
5. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198(a). For example:
a. 30 call tickets received in May 2006, it was observed that 14 call tickets appear to be complaints, but were not identified as such.
b. MDR 2950326-2006-00001 (Alarm Malfunction) initial report was received in April 2006; however the first Call Ticket was not generated until May 15, 2006, the complaint report was not generated until June 2006, and the full investigation was not documented, including potential root causes.
We have reviewed your response and have concluded that it is inadequate because the response states that you will revise your Corrective Action, Complaints and Investigations procedure within 30 days, which has since passed. You have yet to submit your revised SOP. In addition, you have not provided any evidence that you trained your employees on the revised SOP and that you have implemented the revised SOP. Lastly, the response states that you will review all of your 2006 complaints to ensure that they are complete. The response to observation 7 states that this review will be done within 60 days, which has since passed. The response to observation 1 states that the review of the 2006 complaints will be done within 90 days, which has also since passed. With either of the timeframes, no supporting documentatian has been submitted at this time.
6. Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, training of individuals who take service calls is inadequate since they are responsible for identifying complaints and separating them from other issues in a uniform and timely manner; however, they are not accurately identifying all complaints.
We have reviewed your response and have concluded that it is inadequate because the response states that corrective actions for this observation would be completed within 30 days, which has since passed. You have yet to provide any supporting documentation for the corrections, corrective actions, or any preventive actions.
Our inspection also revealed that your device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include,but are not limited to, the following:
1. Failure to adequately document MDR event files, as required by 21 CFR 803.18(b)(1)(i).
For example, your MDR event files must contain: (i) Information in your possession or references to information related to an adverse event, including all documentation of deliberations and decision making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable under 21 CFR 803. The inspection revealed your records do not document your full investigation, including potential root causes of the problem described in MDR 2950326-2006-00001.
2. Failure to investigate and evaluate the cause of an event, as required by 21 CFR 803.50(b)(3).
For example, your firm did not determine the potential root causes of the problem described in MDR 2950326-2006-00001.
Our inspection also revealed that the P.I.N. software with Internet access is adulterated undersection 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(l)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C.360j(g). This device is also misbranded under Section 502(o), 21 U.S.C. 352(o), in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(ii). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
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 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.
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: Food and Drug Administration, Florida District, 555 Winderley Place, Suite 200, Maitland, Florida 32571. If you have any questions about the content of this letter please contact: Mr. Brant M. Schroeder at 407-475-4763.
Finally, you should know that 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 Inspectional Observations, Form 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 violations, and take prompt actions to correct the violations and to bring your products into compliance.
Director, Florida District
Steve Bagga, President
LifeCare Technologies, Inc.
Pascoe Consultant s
13 Queens Road Hale
United Kingdom WA 159HF