GERMAN-BASED EKSA CITED FOR QS, MDR VIOLATIONS
ESKA Implants was issued a May 16 warning letter for quality system (QS) and medical device reporting deficiencies that were uncovered during a November 2005 inspection of the company's Lubeck, Germany, facility. The company manufactures total hip replacement prostheses.
Under the QS regulation, the agency cited the firm for not establishing adequate procedures for implementing corrective and preventive actions (CAPAs). Specifically, the agency said the firm's CAPA procedures do not contain sufficient detail for "analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product."
The CAPA procedures also did not provide enough detail for identifying the actions needed to prevent recurrence of those nonconformities, the FDA said.
ESKA also failed to adequately maintain procedures for identifying, documenting and validating design changes before implementing them, the warning letter says.
In addition, the firm did not maintain appropriate procedures for defining and documenting design outputs compared with design inputs. For example, the device master record (DMR) specifies that cobalt chromium-molybdenum alloy be used to manufacture cementless femoral stems. But the agency identified numerous specification differences between the DMR and the standard, according to the warning letter. ()a href="http://www.fdanews.com/ddl/33_27/" target=_blank>