Troy Hit With Warning Letter Over Quality System Lapses

Quality system lapses — including process validation snafus — failure to address nonconforming products and not evaluating suppliers efficiently are some of the reasons contract device manufacturer Troy Innovative Instruments has fallen afoul of the FDA.

During a June 5 to 30 inspection of Troy’s Middlefield, Ohio, plant, an FDA inspector observed at least six examples in which the firm, which manufactures implantable orthopedic devices, including trocars, lumbar bone screws, rods, nuts and plates, failed to validate a process, according to a Sept. 1 warning letter.

For example, validation studies for a laser etching process that engraves lot numbers on implantables did not include whether the method could result in post-processing metal fatigue. Also, validation studies for a nitric passivation process did not test for the worst-case scenario for load size. In addition, the firm failed to test for the worst-case scenario during electropolishing validation studies.

Validation studies for certain welding processes did not include strength testing of the welds.

The FDA also cited the firm for not determining whether adverse events resulted from reworked products.

The warning letter said the firm did not establish procedures to control products that don’t conform to specifications, and it failed to document in-process inspections and verification activities.

For example, not all nonconforming products were documented, and data are not being captured for potential corrective and preventive actions, an FDA Form 483 notes. In addition, the quality manager told the FDA inspector that only out-of-specification results are documented, and so all acceptance activities during the manufacturing process are not being recorded, the 483 says.

Finally, the warning letter dings the firm for failing to ensure that all suppliers conform to specified requirements.

The letter says suppliers are approved and continue to be used without a review of whether their processes are acceptable.

The FDA inspector noted that the company didn’t include a risk-based approach to its annual evaluation of suppliers since suppliers listed as critical are not reviewed or monitored. Moreover, the firm’s annual review of suppliers only rates suppliers on their late deliveries, dollars rejected, and responsiveness to corrective actions.

The FDA says it received a response dated July 14 to the Form 483, but the agency could not determine its adequacy. It has asked Troy to hire an outside consultant to conduct an audit of the firm’s manufacturing and quality assurance systems. It requested the consultant to certify the audit by March 1, 2016, and also required a subsequent certification one year later.

The firm did not comment by deadline.

The first crucial question devicemakers must answer is when a process must be validated. Order our report Process Validation: A Guide for Devicemakers, which will walk you through each point in the decision-making process, including how to determine if a product can be “fully verified,” and how FDA inspectors define that term.