Company: Laborde Diagnostics at South College
Product: Mammography facility
Date: 9/12/03
The specific deficiency noted above appeared on the MQSA Post Inspection Report, which was given to your facility by the state inspector along with instructions on how to respond to this finding. Your facility responded to this same noncompliance issue in a letter dated September 16, 2002, to the New Orleans District office. The letter stated that to achieve corrective action, your facility would purchase a computerized reportingh system to streamlilne Quality Control (QC) and paatient reporting that includes an extensive medical audit section and analysis. You reported that this system was purchased on September 16, 2002, and would be in place by the next month. However, the state inspector found this same violation during the August 2003 inspection.
This noncompliance violation had been cited during your last three annual inspections. Our letter of December 9, 2002, stated that your facility’s response dated September 16, 2002, failed to adequately respond to this item. Mr. Paul N.
Guidry, Chief Technologist, responded by letter dated December 17, 2002, stating a new software system was purchased which allowed credentialing information to be maintained at your facility. However, the state inspector found this same violation during the August 2003 inspection.
FDA District: New Orleans District Office
