UK Bone Filler Maker Warned Over Purchase Documentation

Penn Pharmaceutical Services, a Wales-based maker of synthetic bone filler, lacked documentation on purchases from Luitpold Pharmaceuticals for one of Penn’s products. Such documents are needed to identify the responsibilities and quality controls for manufacturing the β -TCP 0.5 CC Perio Cups, according to the June 11 warning letter posted recently online.
Devices & Diagnostics Letter