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 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.
Moreover, collimators returned by customers for repair weren’t tested to performance requirements before they were released, and no justification was provided. The FDA found that the firm failed to evaluate the impact of a design change, and it didn’t document results of incoming, in-process and finished device tests.
Other GMP deficiencies uncovered included inadequate corrective and preventive action procedures and failure to establish procedures that ensure nonconforming products were controlled. The firm did not evaluate or document nonconforming products identified during processing and manufacturing. When asked about rework activity, the firm could not locate information on the disposition of several nonconforming products.