Bristol, Rhode Island-based devicemaker Huestis Machine Corp. was cited for numerous GMP failures in an 11-item Form 483 following a September 2017 inspection.
Certification of the company’s X-ray collimators was not based on a testing program in accordance with good manufacturing practices, the FDA said.
There were numerous discrepancies between documented X-ray peak energy values in the collimator leakage test procedure and the production log, and the firm could not provide a documented justification. Similar discrepancies were noted for values listed in the collimator aluminum equivalence procedure and production log with no written documentation.
Other GMP deficiencies uncovered included inadequate corrective and preventive action procedures and failure to establish procedures that ensure nonconforming products were controlled.