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Siemens Warned by FDA on QSR
Jim Dickinson
July 25, 2012
1 Min Read
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A three-month FDA inspection that ended on February at Siemens Healthcare Diagnostics’ facility in Newark, DE, found Quality System Regulation violations in the firm’s manufacturing of in vitro diagnostic products for human use, according to a June 29 Warning Letter from FDA’s Philadelphia District Office. Specific violations noted included:
Failing to establish and maintain adequate procedures to control product that does not conform to specified requirements.
Failing to establish and maintain adequate procedures for rework, including retesting and reevaluation of nonconforming product after rework to ensure that it meets its current approved specifications.
Failing to establish and maintain adequate procedures for implementing corrective and preventive action.
The firm’s responses to the inspectional observations were inadequate, according to the Warning Letter. Siemens was told to take prompt action to correct the violations and to submit a list of specific steps taken with documentation of the steps and a timetable for completion.
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