Recipient:Dentsply International, Inc
Product: dental handpieces and dental accessories
The inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
Failure to maintain procedures to ensure that the device design is correctly translated into production specifications. For example, the [redacted] software source code version 1.6 did not go through a formally documented design transfer process. The source code?s electronic file transfer to the master chip before production release was not documented and the approved source code version 1.6 (hardcopy or electronic file) was not retained under Document Controls.
Issuing Office: Chicago District