Inspections, Compliance, Enforcement, and Criminal Investigations
ffrench Pocket Airway, Inc. 6/5/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
New Orleans District
June 5, 2009
WARNING LETTER NO. 2009-NOL-11
Delivery Signature Requested
Ronald J. French, MD
Owner and President
ffrench Emergency Pocket Airway, Inc.
6123 Marquette Place
New Orleans, Louisiana 70118-6103
Dear Dr. French:
During an inspection of your firm, located at 6123 Marquette Place, New Orleans, Louisiana, on
January 12 and 14,2009, investigators from the United States Food and Drug Administration
(FDA) determined your firm manufactures the LifeStat Emergency Airway Device. 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 are
intended to affect the structure or function of the body.
Our inspection revealed these devices are adulterated under Section 501(f)(1)(B) of the Act, 21
USC 351(f)(1)(B), because you do not have an approved application for premarket approval
(PMA) in effect pursuant to Section 515(a) of the Act, 21 USC 360e(a), or an approved
application for an investigational device exemption (IDE) under Section 520(g) of the Act, 21
USC 360j(g). The device is misbranded under Section 502(0) of the Act, 21 USC 352(0),
because you did not notify FDA of your intent to introduce the device into commercial
distribution, as required by Section 510(k) of the Act, 21 USC 360(k). For a device requiring
premarket approval, the notification required by Section 510(k) of the Act, 21 USC 360(k), is
deemed satisfied when a PMA is pending before the agency [Title 21, Code of Federal
Regulations, Part 807.81(b), (21 CFR 807.8 1(b))]. The information you need to submit in order
to obtain approval or clearance for your device is described on FDA's Internet website at
http://www.fda.gov/cdrh/devadvice/3122.html. FDA will evaluate the information you submit
and decide whether your product may be legally marketed.
The LifeStat Emergency Airway Device was cleared for use in emergency airway obstruction in a non-clinical environment (see K962312). However, the labeling for the LifeStat Emergency Airway Device, including the labeling on your website, http://www.airstat.org/pages/instructions.php, states the device can be used for "retrograde threading of a guide through the vocal cords into the pharynx" and "can thereby enable endotracheal intubation where visualization of the larynx is impossible." The use of the LifeStat Emergency Airway Device for endotracheal intubation constitutes a major change in its intended use, and clearing such an intended use would require additional data to substantiate adequate safety and effectiveness of this device indication. In a letter to your firm, dated September 13, 1996, FDA requested the statements promoting this indication be removed from your labeling. Additionally, the LifeStat Emergency Airway Device was cleared for single patient use and for prescription use only. However, the device labeling, namely The Breath of Life promotional brochure for the LifeStat Emergency Airway Device, included with the sale of the device, does not limit the use of the device to single patient use and prescription use. The labeling on the website and The Breath of Life promotional brochure represent significant changes or modifications in the intended use of the device which require a new premarket notification [21 CFR 807.81(a)(3)(ii)].
The LifeStat Emergency Airway Device, as cleared by the agency, requires the following prescription use statement: "Caution: Federal law restricts this device to sale by or on the order of a [physician or any other practitioner licensed by the law of the State in which he practices to use or order the use of the device]." [21 CFR 801.109(b)(1)]. Without such a statement, the device is misbranded within the meaning of Section 502(f)(1) of the Act, 21 USC 352(f)(1), because labeling for this device fails to bear adequate directions for use. We note the device referenced in the The Breath of Life promotional brochure does not include such a statement.
Our 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 (QS) regulation found at 21 CFR 820. We received two responses from you, on March 20 and May 1, 2009, concerning our investigators' observations noted on the Form FDA 483, List of Inspectional Observations, issued to you. We address these responses 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 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). For example, there are no design control procedures.
We have reviewed your responses and have concluded they are inadequate because your firm did not provide documentation to demonstrate corrective action has been taken to adequately establish and maintain design control procedures.
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, there are no procedures to ensure all purchased or otherwise received product and services from LifeStat Emergency Airway Device's contract manufacturer conform to the specified requirements.
We have reviewed your responses and have concluded they are inadequate because your firm did not provide documentation to demonstrate corrective action has been taken and purchasing controls procedures have been established and maintained. Namely, the (b) (4) procedure, dated April 27, 2009, provided in your firm's response received on May 1, 2009, does not adequately establish procedures for purchasing controls in order to ensure all purchased or otherwise received product and services from the contract manufacturer conform to specified requirements. In addition, you have not provided documentation demonstrating your firm has a written agreement with the contract manufacturer which states the contract manufacturer will notify your firm of any changes to the product.
3. Failure to comply with the requirements for acceptance activities, as enumerated in 21 CFR 820.80(a), including the failure to establish and maintain procedures for acceptance activities. For example, there are no documented procedures defining acceptance criteria for product received from the contract manufacturer.
We have reviewed your responses and have concluded they are inadequate because your firm did not submit documentation to demonstrate appropriate corrective action with respect to acceptance activities has been taken.
4. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure complaints are evaluated to determine whether a complaint represents an event which is required to be reported to FDA under 21 CFR 803, as required by 21 CFR 820.198(a)(3). For example, the (b) (4) procedure, dated April 27, 2009, and provided in your firm's response received on May 1, 2009, and (b) (4) dated September 10, 2006, fail to address evaluations of complaints to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803.
We have reviewed your responses and have concluded they are inadequate because your film did not submit documentation demonstrating corrective action with respect to ensuring appropriate evaluation of complaints has been taken.
5. Failure to establish and maintain procedures for control and distribution of finished devices to ensure only those devices approved for release are distributed and purchase orders are reviewed to ensure ambiguities and errors are resolved before devices are released for distribution, as required by 21 CFR 820.160(a). For example, your firm did not establish and maintain procedures for control and distribution of finished devices.
We have reviewed your responses, including the (b) (4) procedure, and have concluded they are inadequate because your firm did not provide documentation to demonstrate corrective action has been taken and appropriate procedures for control and distribution have been established and maintained.
6. Failure to establish and maintain procedures to control labeling activities, as required by 21 CFR 820.120. For example, your firm did not establish and maintain procedures to control labeling activities.
7. Failure to ensure device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution, as required by 21 CFR 820.130. For example, your firm has not ensured distributing each device in a small, clear, plastic zip lock bag packed within a padded envelope is sufficient to protect the device from alteration or damage.
8. Failure to establish and maintain procedures for the control of storage areas and stock rooms to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 CFR 820.150. For example, your firm did not establish and maintain procedures for the control of storage areas and stock rooms.
Deviations 6-8 above from the QS regulations were not included in the issued Form FDA 483.
Our inspection revealed your 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. Your firm has failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17, which provide adequate detail to meet the following requirements:
1. Internal systems which provide for:
(a) Timely and effective identification, communication, and evaluation of events which may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1);
(b) A standardized review process for determining when an event meets the criteria for reporting under 21 CFR 803, as required by 21 CFR 803.17(a)(2); and,
(c) Timely transmission of complete medical device reports to the manufacturer or to FDA, or to both if required, as required by 21 CFR 803.17(a)(3).
2. Documentation and recordkeeping requirements for systems to ensure access to information which facilitates timely follow-up and inspection by the FDA, as required by 21 CFR 803.17(b)(4).
We have reviewed your responses and have concluded they are inadequate because your firm did not submit documentation to demonstrate corrective action has been taken and MDR procedures have been developed and implemented appropriately. Your firm's updated MDR procedure, (b) (4) remains inadequate, as it fails to address the deviations noted above.
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. 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 QS 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 violations, or similar violations, from recurring. 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 Kari L. Batey, Compliance Officer, at U.S. Food and Drug Administration, at the address above. If you have any questions about the content of this letter, please contact Ms. Batey at (615) 366-7808.
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, 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.
H. Tyler Thornburg
New Orleans District Office
Enclosure: Form FDA 483