Private equity firms such as Nordic Capital Fund IX invest in assets for great returns. In the case of FDA regulated life science industry requires ensuring adherence to GxPs and compliance with FDA regulatory requirements. Nordic acquired Orchid Orthopedic Solutions January of this year. Trouble soon followed shortly thereafter.
Orthopedics published the FDA recently inspected Orchid Orthopedic Solutions and issued the warning letter citing both manufacturing defects and possible sources of infection in its processes for including bone-ingrowth stimulating coatings to orthopedic implants.
The FDA warning letter was targeted at Orchid’s Farmington Hills Michigan, plant which does coating for implants Orthopedics reported. The FDA visited the facilities February 4-15, 2019.
Apparently on March 11, 2019, Orchid responded to the findings, but a lengthy FDA letter retorted their response “inadequate on several matters.” Orchid reports that there are so many redactions that it would appear the FDA is “bending over backwards” for Orchid’s trade secret content.
Follow the link to the source for more information; information on the warning letter is found directly to the FDA website.