Failure to document re-worked nonconforming products and to establish procedures for controlling process parameters were just a few of the many quality system failures documented in a May 13 warning letter to devicemaker Orchid Orthopedic Solutions following a Feb. 4-15 inspection of its Holt, Michigan plant.
Orchid specializes in applying coatings to orthopedic implants that promote bone growth.
The firm failed to establish adequate procedures to monitor the quality of water used in the device cleaning process during manufacturing, the warning letter says. For example, the water system was not always sanitized, and testing for organic carbon was not always performed.
Additional testing procedures were unclear and Orchid’s CAPA procedures didn’t analyze sources of quality data to identify existing and potential causes of nonconforming products.
Other citations included failure to validate the manual cleaning process for implants, and there was no assurance that the devices were processed under normal or worst-case operating conditions.
Read the warning letter here: www.fdanews.com/05-23-19-OrchidOrthopedicSolutionsWL.pdf.