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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SCM True Air Technologies LLC 7/3/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771 

 

July 3, 2013
 
WARNING LETTER                                                                      VIA UPS
CIN 13-407452-27
 
Robert W. Keesaer
Owner
SCM True Air Technologies, Inc.
7955 National Turnpike, Unit 100
Louisville, KY 40214-4903
 
Dear Mr. Keesaer:
 
During an inspection of your firm located in Louisville, KY,on May 6-24, 2013 an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures bariatric beds and low air loss controllers for alternating pressure air flotation mattresses. 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 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 a response from John N. Keesaer, President, dated June 4, 2013, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (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 procedures to control product that does not conform to specified requirements,as required by 21 CFR 820.90(a). Specifically;
 
a)    “True-Air Complaints, CAPA and Nonconforming Products/materials” procedure, QA-002, Rev. 01, dated 1/11/08 does not address performing an evaluation, including a determination of the need for an investigation and notification of the persons or organization responsible for the nonconformance.
  
b)    A “Complaint/CAPA/NCP” form, which is required by your procedure described above, was not initiated for the 34 of 48 beds that your employee identified as having nonconformances upon delivery to (b)(4). No evaluation and no investigation were performed.    
  
Your response is not adequate. Your response does not address corrective actions that you will take to assure complete nonconforming product procedures, that address evaluation of nonconformances have been developed; nor does it address the steps you are taking to assure all nonconformances are documented.
 
2)    Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated units, as required by 21 CFR 820.198(a). Specifically;
 
A complaint letter received on February 27, 2013 from the (b)(4) regarding 48 bariatric beds having quality defects, such as corrosion on bed frames, damaged headboards, protruding side rails, etc., was not entered into your complaints system per your “Complaints, CAPA and Nonconforming Product/materials” procedure.
 
Your response is not adequate. Your response does not address the corrective actions you are taking to assure all complaints are documented and processed according to your written procedures.
 
3)    Failure toestablish and maintain procedures to  ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the patient and user, as required by 21 CFR 820.30(c). Specifically;
 
a)    (b)(4) Design procedure, QSM-001, Rev 1.1, dated 6-23-2011, used to design SCM bariatric beds that were manufactured at the (b)(4) facility, is inadequate in that it does not address defining performance characteristics, safety and reliability requirements, standards and reliability requirements, environmental requirements, physical characteristics, and labeling and packaging requirements. Additionally, the inputs for these bariatric beds are incomplete. For example, safety factors, such as entrapment; instructions for use and labeling requirements; environmental requirements; and physical characteristics, such as the ability of the bed to move through doorways, are not included.
 
b)    True-Air Design Controls procedure, #QA005 Rev 2, dated 10/12/08, used to design medical devices manufactured at your Louisville facility, has not been implemented. The design inputs for the JK bariatric beds are incomplete. For example, safety factors, such as entrapment; instructions for use and labeling requirements; environmental requirements; and physical characteristics are not included.
 
Your response is not adequate. Your response does not address corrective action for the sections of the design control procedures that pertain to design inputs; nor does it address developing complete design inputs for the 2 bariatric bed designs discussed above.
 
4)    Failure to establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation for conformance to design input requirements, as required by 21 CFR 820.30(d).
 
a)    (b)(4) Design Controls procedure, QSM-001, Rev 1.1, dated 6-23-2011, used to design SCM bariatric beds that your company manufactured at the (b)(4) facility, is inadequate in that it does not contain or make reference to acceptance criteria and does not ensure that the outputs that are essential to the proper functioning of the device are identified. Additionally, the design outputs for these beds are incomplete. For example, there are no approved instructions for use and labeling specifications.
 
b)    True-Air Design Controls procedure, #QA005 Rev 2, dated 10/12/08, used to design medical devices manufactured at your Louisville facility, has not been implemented. The design outputs for the JK bariatric beds are incomplete. For example, finished device specifications, finished device acceptance criteria, process specifications, device history record forms, and labeling have not been completed, as required by your procedure.
 
Your response is not adequate.  Your response does not address corrective action for the sections of the design control procedures that pertain to design outputs; nor does it address developing complete design outputs for the 2 bariatric bed designs discussed above.
 
5)    Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). 
 
a)    (b)(4) Design Controls procedure, QSM-001, Rev 1.1, dated 6-23-2011, used to design SCM bariatric beds that your company manufactured at the (b)(4) facility, is inadequate in that it does not address the testing required to determine whether the design outputs meet the design inputs. Additionally, design verification for the bariatric beds is incomplete in that all outputs were not verified to meet the input requirements.
 
b)    True-Air Design Controls procedure, #QA005 Rev 2, dated 10/12/08, used to design medical devices manufactured at your Louisville facility, has not been implemented. For example, a design review meeting memo, dated February 22, 2012, for the JK bariatric beds, lists several verification tests that passed.   The design verification activities, including design tested, methods, results, dates and individuals performing these verifications are not documented, as required by your True-Air Design Controls procedure.
 
Your response is not adequate. Your response does not address corrective action for the sections of the design control procedures that pertain to design verifications; nor does it describe the steps you are taking to assure all design verifications for the 2 bariatric bed designs discussed above are completed.
 
6)    Failure to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Specifically;
 
a)    (b)(4) Design Controls procedure, QSM-001, Rev 1.1, dated 6-23-2011, used to make design changes to 11 E1000 Bariatric beds to convert them to E850 Bariatric beds at the (b)(4) facility, does not address design changes. For example, the changes made to convert the E1000 beds to the E850 beds were not documented and verification and/or validation were not performed. Additionally verification was not performed on the design change from 2 to 4 side rails. 
 
b)    True-Air Design Controls procedure, #QA005 Rev 2, dated 10/12/08, used to design medical devices manufactured at your Louisville facility, has not been implemented. For example, the design changes made to the low air loss controller and the controller’s micro-processing board were not verified and/or validated, reviewed and approved, as required by your True-Air Design Controls procedure.
 
Your response is not adequate. Your response states that “proper documentation will take place”. It does not provide the actions that you will take to assure your design change procedure will be implemented, and the review of other design changes to assure they were verified and/or validated.
 
7)    Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically;
 
a)    The (b)(4) Design Controls procedure, QSM-001, Rev 1.1, dated 6-23-2011, used to design the E850 Bariatric beds at the (b)(4) facility, has not been implemented, in that design validation was not performed on the E850 beds. Additionally, the risk analysis is incomplete and how the levels of risk are calculated is not defined. Entrapment, Overweight Patient and Fire Prevention are the only risk identified; and the “Risk of Injury” and “Risk Level” were not determined for these risks.
  
b)    True-Air Design Controls procedure, #QA005 Rev 2, dated 10/12/08, used to design medical devices manufactured at your Louisville facility, have not been implemented. For example, the manufacturing specifications and the manufacturing records for the JK bariatric beds used for design validation were not documented.  Additionally, the risk analysis does not include all risks associated with the device and how the levels of risk are calculated is not defined. For example, the risk of the rails collapsing in the lock position was not addressed.
 
Your response is not adequate. Your response does not address the steps you are taking to assure complete risk analyses are performed for the 2 bariatric beds.
 
8)    Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure the product meets its current and approved specifications, as required by 21 CFR 820.90(b)(2). Specifically;
 
a)    There are no written rework procedures and rework is not documented.
 
i)    The rework performed on 34 nonconforming E850 bariatric beds by your employee after arrival at the (b)(4) was not documented.
 
ii)    The rework of used motors from low air loss controllers from returned rented devices and the placement of these reworked motors into new devices are not documented.
 
Your response is not adequate. It does not address the actions you will take to assure rework procedures are established and rework is documented.
 
9)    Failure to maintain a device master record, as required by 21 CFR 820.181. Specifically;
 
A device master record, including the component specifications; production process specifications;quality assurance procedures and specifications, including finished device acceptance; packaging and labeling specifications; and installation, maintenance and servicing procedure and methods, was not established for the JK bariatric beds.
 
Your response is not adequate. Your response states that all blueprints will be drawn and all other process controls will also be addressed. It does not include a detailed description and procedures regarding what process controls will be implemented. It also does not address quality procedures, component specifications, packaging and labeling, maintenance and service.
 
10)    Failure to maintain device history records (DHR’s) to demonstrate the device was manufactured in accordance with the DMR and the requirements of this Part, as required by 21 CFR 820.184. Specifically;
 
a)    Device history records, including the dates of manufacture, quantity released for distribution, acceptance records, primary identification label, and any device identification used, were not created for the 23 JK bariatric beds that were manufactured since January of 2010.
 
Your response cannot be assessed at this time. Your response states that you will design and implement a quality system before further manufacturing is performed. 
 
11)    Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically;
 
a)    You have not implemented your “Vendor Control and Purchasing” procedure, QA-007 Rev. 01, dated 1/11/08 in that the following suppliers have not been evaluated and are not listed on your approved supplier list:
 
-    The supplier of the quality manual, including the design and manufacturing specifications of the E850 bariatric beds. You also did not evaluate to any specified requirements the E1000 bariatric beds you purchased from this supplier and converted to E850 beds; nor did you evaluate to any specified requirements the manufactured E850 beds prior to purchase.  
 
-    The contract manufacturer of the JK bariatric beds.
 
-    The on-line supplier of used motors that are components of the low air-loss pressure mattresses.
 
-    The suppliers of steel and actuators that are components of the JK bariatric beds.
 
b)    You have not attempted to obtain written agreements with your suppliers.
 
Your response is not adequate. Your response states that you will update the approved vendor list, but it does not address the requirements, including quality requirements that must be met by each supplier; and the type and extent of control that will be exercised.
 
12)    Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(a). Specifically;
 
No acceptance procedures and criteria have been established for the used motors that you purchase on (b)(4) and place in the low air loss controllers for alternating pressure air flotation mattresses. Additionally, the acceptance of these motors is not documented.
 
Your response is not adequate. It does not address the actions you will take to assure incoming acceptance procedures and acceptance criteria are established; and the acceptance of incoming product is documented.
 
13)    Failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements, as required by 21 CFR 820.200(a). Specifically;
 
You do not have written service procedures, and there is no documentation of the service performed on low air pressure mattress controls; that are returned after being rented to a facility, and are serviced by your company prior to being rented to another customer.
 
Your response is not adequate. Your response states that the service is performed mainly by SCM. SCM is a company owned by you, located at the same address as SCM True Air Technologies and both companies share several of the same employees. Therefore, FDA considers service being performed by SCM, as service performed by the original manufacturer. Please provide the corrective actions you will take to assure service procedures are established and service is documented.  
 
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.
 
We are requesting that you submit to this office, according to the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirements of the device quality system regulation (21 CFR Part 820). You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections should be submitted to this office by the following date:
 
  • Initial certifications by consultant and establishment – February 1, 2014.
 
Please notify this office in writing within fifteen working days from the date you receive this letter of the specific steps that 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.
 
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 about the content of this letter please contact Ms. Brackett at (513) 679-2700, ext. 2167, or by facsimile at (513) 679-2773.
 
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 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. 
 
 
Sincerely yours,
/S/                                                           
Paul J. Teitell
District Director
Cincinnati District