Inspections, Compliance, Enforcement, and Criminal Investigations
SCM True Air Technologies LLC 24-Sep-07
Department of Health and Human Services
Public Health Service
Cincinnati District Office
September 24, 2007
VIA FEDERAL EXPRESS
Mary Louise Keesar
SCM True Air Technologies LLC
7955 National Turnpike, Unit 100
Louisville, KY 40214-4903
Dear Mrs. Keesar:
During an inspection of your firm located in Louisville, KY on August 16 and 17, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures alternating pressure and low air loss mattresses used to help prevent and treat decubitus ulcers. 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. In addition, FDA regulations specifically provide that alternating pressure air flotation mattresses are Class II devices. Title 21,Code of Federal Regulations (C.F.R.), § 880.5550.
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 manufacturing, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 C.F.R. Part 820. We received a response from John N. Keesar, Vice President, dated September 10, 2007, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We acknowledge that you have promised to address the issues cited in the FDA-483. Nevertheless, your response by itself is inadequate to address the violations discussed below because you must properly implement, document, and maintain each corrective action to ensure its effectiveness. Further, we cannot determine whether the measures you have promised are adequate without reviewing the appropriate supporting documentation. We discuss our specific document requests below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1) Failure of management with executive responsibility to assure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization. [21 CFR 820.20]
Specifically, from 2005 to the start of this inspection, your firm manufactured approximately 400 low air loss and alternating pressure mattresses. During this time you had not established the following:
• Failure to establish procedures for implementing corrective and preventive actions. [21 CFR 820.100]
• Failure to establish procedures to control product that does not conform to specified requirements. [21 CFR 820.90]
• Failure to establish procedures to control and monitor the production processes for the mattresses. [21 CFR 820.70]
• Failure to establish procedures for in-process and finished device testing; and failure to perform this testing on the mattresses. Failure to perform inspections, testing and other verification activities for incoming product. [21 CFR 820.80]
• Failure to establish procedures for purchasing activities; and failure to ensure that purchased or otherwise received product conform to specified requirements. [21 CFR 820.50]
• Failure to establish procedures to control labeling activities. [21 CFR 820.120]
• Failure to establish procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. [21 CFR 820.160]
We acknowledge that in your response letter and during the inspection you informed the FDA investigator that your firm hired a consultant; and that you have developed written procedures to address the above Quality System regulation violations. Your response states that all Quality System procedures have now been implemented. Please provide a copy of the records documenting the training your employees received on these new procedures, as well as copies of the procedures that address the above violations.
2) Failure to implement procedures for receiving, reviewing, and evaluating complaints; to maintain complaint files; and to review and evaluate complaints to determine whether an investigation is necessary. [21 CFR 820.198] Specifically;
• The review of the delivery tickets received from one rental customer between June of 2006 and June of 2007 by the FDA investigator revealed that there were 37 complaints by this customer. Your firm did not review, evaluate, and investigate these complaints; and complaint files were not established.
• The review of these delivery tickets during this timeframe also revealed that 237 of the mattresses were picked-up or replaced. Your firm did not document the reason for replacement and if these replacements were the result of a complaint.
There is not enough information in your response letter to determine if your response is adequate. Please submit copies of your Complaint, Corrective and Preventive Action, and Nonconforming Products/Materials procedures and an example of completed forms that accompany these procedures.
3) Failure to maintain device history records (DHRs) for each low air loss and alternating pressure mattress manufactured; and failure to establish procedures to ensure that DHRs for each unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the requirements of the Quality System regulation. [21 CFR 820.184]
Specifically, since 2005, your firm has manufactured approximately [redacted] of these mattresses. Your firm did not establish device history records for these units.
There is not enough information in your response letter to determine if your response is adequate. Please submit copies of your procedures that address maintaining device history records, as well as, a copy of a completed device history record for each type of mattress. Also include documentation showing that production employees were trained on how to complete the device history record.
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 applications for Class III devices to which the Quality System regulation deficiencies 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 within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct these noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation for the corrective actions 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 Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 167, or you may forward a facsimile to her at (513) 679-2773.
Finally, you should know that this letter is not intended to be an all-inclusive list of 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 to bring your products into compliance.
Carol A. Heppe