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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 Response Letter

Friday, October 05, 2007

Ms. Gina Brackett
Compliance Officer
Cincinnati District, Food and Drug Administration
Central Region
6751 Steger Drive
Cincinnati, Ohio 45237-3097

In response to Warning Letter issued to SCM True Air Technologies LLC, Louisville,  KY, by on September 24, 2007

Dear Ms. Brackett:

We acknowledge receipt of the Warning Letter issued on September 24th. Further, we do not disagree with the findings of this Warning Letter. However, we would like to reiterate the statement in our initial response to the Form 483, that these findings have been addressed by a new, formalized Quality System put in place on August 16th, 2007. During the inspection of August 16-17, we had not yet generated any new records under this system, but we are now fully following the new system and believe that we are now in full compliance. We are anxious to achieve and maintain full compliance with the Quality System regulation, and have implemented this new system to achieve that goal.

Three observations were noted on this Warning Letter. Our responses are included in this letter for each observation. Attached documents and forms will be included with this response.

Observation 1 - Reply

On August 16, 2007, we implemented a complete Quality System to address all of the issues. We take no issue with this Observation . We have been aware that this situation existed and took steps to correct it before the August 16-17 inspection, and our new Quality System is now in place and operational. We believe we are now fully compliant with all bullet points in this Observation. We have included a copy of our Document Index, outlining our new Quality System, and are willing to provide copies of any of our procedures and records to FDA on request.

SCM True Air Technologies LLC has made a substantial investment in time, money and manpower to correct our regulatory profile and achieve full compliance with the Quality System regulation. It is our intent to be fully in compliance with the implementation of our August 16th Quality System, and to have full records and procedures addressing all items well before any future FDA inspections. We believe our new Quality System will achieve that goal.

Attached to this letter are copies of our new procedures for complaints and corrective and preventive actions (QA-002) production and process controls (QA-009) receiving, incoming and finished device inspections (QA-010) purchasing (QA-007) identification and traceability (QA-008) and packaging and labeling (QA-012.) We have also enclosed several examples of documents generated under these procedures .
Observation 2 - Reply

QA-002, Complaints, Corrective & Preventive Actions and Non-conforming products/materials, is intended to address the issues described in Observation 2. We are aware that failure investigations need to be performed and documented, and are confident that QA-002 fully meets
the requirements of 21CFR 820.198.

As noted above, we have enclosed a copy of QA-002 with this response, along with several examples of documents generated under this procedure. As of the date of the inspection, we had not yet generated any records under this procedure, as it had been only very recently

Observation 3 - Reply

QA-010, Receiving, In-Process and Finished Device Inspection, was implemented to address this issue. As part of this procedure, we have also implemented QA-010.1, QA-010.2, and QA-010.3, which are the Device Master Record forms for product produced under this procedure. We have enclosed a copy of QA-010, QA-010.1, QA-010.2, and QA-010.3, as well as examples of completed Device History Record forms for our products, for your examination.

Management Statement of Policy

It is our intent to comply fully with the FDA Quality System regulation. We believe our new Quality System documents place us in compliance, and address the three Observations listed in the Form 483 issued on August 17th, 2007.

FDA's policy states that responses to Warning Letters will be posted on the FDA website at the Warning Letter recipients request. We therefore request that this letter be posted on FDA's website. We have enclosed an electronic copy of this letter on CD to facilitate this posting.






John N. Keesaer
Vice President
SCM True Air Technologies

Warning Letter, issued September 24th, 2007
Copy of Form 483
Document Index
QA-002, Complaints, Corrective & Preventive Actions, and Non-conforming products/materials
QA-007, Vendor Control and Purchasing
QA-008, Identification and Traceability
QA-009, Production and Process Controls
QA-010, Receiving, In-Process and Finished Device Inspection
QA-0 1 2, Packaging and Labeling
QA-0 13, Records