Audit, Inspection Failures Cited in Huestis Warning Letter

Huestis Machine Corporation, a maker of X-ray collimators, radiotherapy simulators and universal urology exam chairs and tables, landed an FDA warning letter for slip-ups related to product inspections and internal quality audits.

According to the Aug. 6 letter posted recently online, 14 of 15 collimator in-process inspection records contained in one work order were filled out with passing results, initialed and signed before the test was conducted.

Additionally, the company’s assistant quality manager and quality control inspector conducted internal quality audits in areas for which they were responsible. Such audits are a repeat problem from a June 2011 inspection of the Bristol, R.I., site.

The FDA investigator also found product storage issues, citing the company for not doing enough to prevent mix-ups. Collimators awaiting repair were observed next to products waiting to be scrapped and products in the process of being built.

Complaint handling was another problem, as Huestis could not provide a specific procedure for the activity. “A review of 53 reports monitored by your firm using Problem Log/Return Authorization Entry Forms revealed at least 18 of these reports involved performance issues that should have been identified as complaints, including one report involving collimator blades opening during exposure, which could result in a patient being exposed to more radiation than intended,” the letter says.

Responsibilities for making complaint, MDR and CAPA determinations were not accurately defined in the company’s work instruction.

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