An FDA inspection of Highland Industries’ Cheraw, South Carolina facility revealed quality system deficiencies including missing validation and manufacturing records and test reports, along with a slew of other documentation failures.

The company manufactures composites for medical devices such as imaging equipment, implants, orthopedics and prosthetics.

Process validation activities and results weren’t documented and approved, according to the 483, which said that lack of adequate validation resulted in the manufacturing process not having defined operating parameters.