Inspections, Compliance, Enforcement, and Criminal Investigations
AireRx Healthcare, LLC 7/27/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
July 27, 2012
WARNING LETTER NO. 2012-NOL-27
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Daniel M. Me Vicker
AireRx Healthcare, LLC
170D East Main Street, Number 271
Hendersonville, Tennessee 37075
Dear Mr. Me Vicker:
During an inspection of your firm, located at 1016 Lavern Circle, Hendersonville, Tennessee, on April 9, 10, and 13, 2012, investigators from the United States Food and Drug Administration (FDA) determined your firm manufactures wheelchair cushions. 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 to affect the structure or any function of the body.
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed the "Products" section of your website, www.airerx.com/Cushions.aspx, for the Cool-Comfort wheelchair cushions. The Cool-Comfort wheelchair cushions are adulterated under Section 501(f)(1)(B) of the Act [21 USC§ 351(f)(1)(B)], because your firm does 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 under Section 520(g) of the Act [21 USC§ 360j(g)]. The devices are also misbranded under Section 502(o) of the Act [21 USC§ 352(o)], because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by Section 510(k) of the Act [21 USC§ 360(k)]. For example: The claims to "reduce heat, moisture and shear-major causes of skin tissue trauma" constitute claims outside the wheelchair component classification, Title 21, Code of Federal Regulations (21 CFR), Part 890.3920. Therefore, the Cool-Comfort wheelchair cushions require a premarket notification, as required by 21 CFR 807.80(a). For a device requiring premarket approval, the notification required by Section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81 (b)]. The kind of information your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. FDA will evaluate the information your firm submits and decide whether the product may be legally marketed.
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 do not comform with the current good manufacturing practice requirements of the Quality System regulation found at 21 CFR 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example: (b)(4) does not contain any provision for complaints that represent a reportable event under the FDA's Medical Device Reporting (MDR) requirements to be reviewed, evaluated, and investigated; and, your firm has not reviewed complaints to determine if they represent a MDR reportable event.
2. Failure to maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b).
For example: (b)(4) does not contain any requirement for documentation of the rationale for not performing a complaint investigation and the name of the individual responsible for the decision not to investigate. In addition, 17 of 24 complaint records reviewed contained complaints which were not investigated, and a rationale or name of a responsible individual was not documented.
3. Failure to establish and maintain adequate procedures to control product which does not conform to specified requirements, as required by 21 CFR 820.90(a).
For example: (b)(4) indicates whenever a nonconformance is identified, it is documented in a (b)(4) but your firm did not generate (b)(4) for any of the nonconformances identified between 2010 and 2012.
4. Failure to document acceptance activities as required by 21 CFR 820.80(e).
For example: Your firm has not documented the results of any receiving acceptance activities or the review, approval, and release of finished devices.
5. Failure to establish and maintain adequate 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 does not have any supplier control procedures and has not documented any of the supplier audit activities performed on the contract manufacturer in (b)(4)
6. Failure to establish adequate procedures for quality audits and conduct those audits to assure the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
For example: (b)(4) requires "each activity is audited at least once a year," but your firm did not perform any quality audits between 2010 and 2012.
7. Failure of management with executive responsibility to adequately review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of 21 CFR 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).
For example: (b)(4) requires management reviews be held at least twice a year, but no management reviews have been performed since June 16, 2010. In addition (b)(4) requires management reviews include 13 specified topics, but the meeting held on June 16, 2010, only addressed quality audits.
8. Failure to maintain adequate device master records (DMRs), as required by 21 CFR 820.181.
For example: Your firm has not maintained DMRs for its SPC and SPPC models of wheelchair cushions.
9. Failure to establish adequate procedures for identifying training needs and ensuring all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).
For example: (b)(4) requires training effectiveness evaluations be performed, including follow up evaluations, correlation of training with non conformities and system failures, and global evaluation of training by management review. However, your firm has not performed any training effectiveness evaluation activities.
Our inspection also 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, as required under Section 519 of the Act [21 USC§ 360i], and 21 CFR 803-MDR. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
Under Section 510 of the Act [21 USC§ 360], manufacturers of medical devices are required to annually register with FDA. In September 2007, Section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (Section 510(p) of the Act, 21 USC§ 360(p)] during the period beginning October 1st and ending December 31st of each year. Our records indicate your firm has not fulfilled annual registration and listing requirements for fiscal year 2012.
Therefore all of your firm's devices are misbranded within the meaning of Section 502(o) of the Act [21 USC§ 352(0)], because the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 510 of the Act [21 USC§ 360], and were not included in a list, as required by Section 510(j) of the Act [21 USC § 3600)].
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Federal agencies may be advised of the issuance of warning letters pertaining to devices so they may take this information into account when considering the award of contracts.
Additionally, PMA applications for Class III devices to which the Quality System regulation violations 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) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from< recurring. Include documentation of the corrective actions (including any systemic corrective actions) your firm has taken. If your firm's planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this warning letter.
Your firm's response should be sent to: Mark W. Rivero, Compliance Officer, at the address above. If you have any questions about the contents of this letter, please contact: Mark W. Rivero at (504) 832-1290, extension 1103.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the lnspectional Observations, FORM FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems.
Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Patricia K. Schafer
New Orleans District
Enclosure: FORM FDA 483 dated April 30, 2012
cc: Keith Ford, General Manager
AireRx Healthcare, Inc.
170D East Main Street
Hendersonville, Tennessee 37075