Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New Orleans District
404 BNA Drive Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
October 17, 2008
WARNING LETTER NO. 2009-NOL-01
Delivery Signature Requested
Donald F. Maples, Jr., CEO
60618 1h Street S.E.
Cleveland, Tennessee 37311
Dear Mr. Maples:
During an inspection of your firm, located in Cleveland, Tennessee, on May 19-23, and June 3, 2008, an investigator from the United States Food and Drug Administration (FDA) determined your firm manufactures automated lift chairs. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code, Section 321(h) (21 USC 321), 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 these devices are adulterated within the meaning of Section 501(h) of the Act (21 USC 351(h)), as 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, Part 820 (21 CFR 820). At the close of this inspection, the FDA investigator issued a Form FDA 483, Inspectional Observations to Mr. Mathew P. Shipton, Plant Manager and Compliance Manager. This office has not received a written response to the Form FDA 483, which cited, but was not limited to, the following violations:
1. Failure to maintain device master records (DMRs) for the automated lift chairs which include or refer to the location of the device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and installation, maintenance, and servicing procedures and methods [See 21 CFR 820.181]. Although your firm maintains device history records required under 21 CFR 820.184, it must also maintain DMRs, so it can exercise control and accountability over the manufacturing activities related to your device and, thereby, maximize the probability the finished device conforms to its design specifications.
2. Failure to establish and maintain procedures to ensure all purchased or otherwise received products and services conform to specified requirements [21 CFR 820.50]. As the contract manufacturer of the automated lift chairs, your firm should have a written agreement with the firm contracting for the manufacture of the device. No vendor audits are performed [21 CFR 820.50(a)(1)], and there is no written agreement between the vendor and its suppliers [21 CFR 820.50(a)(2)].
3. Failure to establish and maintain written procedures for acceptance of incoming components used to make finished devices [21 CFR 820.80(a)], and failure to perform inspections of incoming components to verify they conform to specified requirements [21 CFR 820.80(b)].
4. Failure to establish and maintain procedures for Corrective and Preventive Actions (CAPA) to determine the cause of non-conforming product, and failure to document CAPA activities [21 CFR 820.100(a)(1) and (2); and (b)]. Your firm discards rejected products with no investigation into the component failure. You have no reporting mechanism in place to trend product failures and to report them to the device originator. Specifically, transformers, hand controls, and lift frames.
5. Failure to follow your written procedures regarding the control of nonconforming products [21 CFR 820.90(a)], and failure to document the disposition of nonconforming products [21 CFR 820.90(b)(1)]. You do not investigate the reason components fail, you do not have a consistent policy regarding disposition of non-conforming products, and you do not contact suppliers regarding their defective components.
6. Failure of your designated management representative to ensure your firm has a quality system which is implemented and maintained [21 CFR 820.20].
7. Failure to conduct quality audits to assure the quality system for your manufacture of automatic lift chairs complies with the QS regulation and is effective [21 CFR 820.22]. As the manufacturer of a finished device, you are required to conduct such audits yearly.
You should take prompt action to correct these 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 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. 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 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.
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, 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.
Your response should be sent to: Karl L. Batey, Compliance Officer, 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.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483