FDA issued a warning letter to Polymer Technology Systems after finding fault with certain practices at its Indianapolis in vitro diagnostic production plant.
In a letter published online Tuesday, FDA takes PTS to task for allegedly failing to establish processes that ensure products conform to specifications, or perform timely investigations of non-conformance.
PTS responded to the concerns earlier this year but was unable to appease FDA, in part because of its failure to show it had a standardized approach for checking a certain aspect of device conformity.
PTS manufactures point-of-care diagnostics for use on patients with diabetes, heart disease, kidney problems and other chronic conditions at a facility in Indiana. FDA inspectors visited the facility early in 2019 and left with a list of concerns about its manufacturing practices.
In a March 8 response to regulators' concerns outlined in an FDA form Feb. 15, PTS said it would add a description of how to perform a visual inspection to its production instruction checklist. However, FDA found the response lacking, noting that PTS failed to show how it would standardize the visual inspection across different operators.
The July 31 warning letter lists five sets of manufacturing problems, plus two issues related to compliance with other rules. FDA begins with a criticism of PTS' failure to establish "quantitative mixing speeds to ensure that a homogenous solution is maintained." Inspectors identified the problem after seeing PTS use products with different speed settings during the process.
The warning letter also addresses PTS' handling of corrective and preventative action (CAPA) investigations. FDA identified seven CAPA investigations that had missed deadlines set by PTS. In one case, the CAPA investigation overran by 49 days before the deadline was extended.
FDA also picked up on problems with PTS' compliance with reporting requirements. Inspectors found a report of a battery malfunction involving a heart disease diagnostic device that caused a plastic tablecloth at a hospital to melt. FDA thinks the malfunction is a reportable event but PTS failed to submit a medical device report (MDR) on time.
"Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties," the warning letter states.
A May 7 response from PTS revealed it conducted a two-year retrospective review and submitted MDRs covering the aforementioned incident and 37 others, and made changes to its handling of complaints. However, FDA wants to know more about the new procedures put in place by PTS before ruling that its approach to complaints and reporting is up to standard. The agency asked for a response within 15 business days.