FDA WARNS MAMMOGRAPHY CLINIC OF QUALITY STANDARDS VIOLATIONS
The FDA Aug. 2 warned a Mississippi mammography clinic that it had violated both state and federal quality standards.
The warning letter, posted to the FDA website Aug. 8, was issued to the Women's Breast Care Clinic after two separate inspections of the facility on June 19 and 29.
It indicated the facility was in violation of the Mammography Quality Standards Act. It also noted a prior inspection by a Mississippi health official who had cited the firm for faulty recordkeeping.
The FDA pointed to Level 1 processor quality control (QC) problems in mammography rooms at the clinic, where records were missing for at least 30 percent of operating days during one month, and for at least five consecutive days and four weeks in two other instances.
The facility also did not have adequate procedures for infection control or didn't follow them when required, the FDA said. The clinic failed to maintain corrective actions for processor QC. (http://www.fdanews.com/ddl/33_33/)
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