An FDA inspection of Highland Industries’ Cheraw, South Carolina facility uncovered numerous quality system deficiencies including missing validation and manufacturing records and test reports, along with a slew of other documentation failures.
Highland Industries 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 and specifications for ozone levels.
The FDA found no manufacturing records or test reports for various process validation equipment installations and performance qualifications.
The firm also lacked procedures for finished device acceptance to ensure finished devices meet acceptance criteria. Acceptance activities required to meet the device master record specifications were not defined, the associated data is not reviewed, and there was no documented signature and date authorizing the release of manufactured devices, the agency said.
Read the 483 here: www.fdanews.com/10-25-19-highlandindustriesinc483.pdf.