FDA warns Indian testing firm, two device makers and a university lab
In four warning letters released on Tuesday, the US Food and Drug Administration (FDA) details issues observed at an Indian contract testing laboratory, two medical device makers and a university laboratory that ran a nonclinical trial for a medical device.Shriram Institute for Industrial Research
In its warning letter to Delhi, India-based Shriram Institute for Industrial Research, FDA cites the contract testing laboratory for repeat good manufacturing practice (GMP) violations and data integrity issues uncovered during an inspection in October 2019.
FDA says the company, which offers testing services for active pharmaceutical ingredients (API) and finished drugs, did not enable the audit trail function on its high-performance liquid chromatography (HPLC) units until just before the inspection took place. FDA says this is a repeat violation from a 2016 inspection.
FDA also says the company’s quality unit failed to ensure its personnel followed written procedures, noting that multiple samples tested between March and September 2019 that yielded out-of-specification (OOS) results were not investigated.
“Your head of quality assurance informed out investigator that failures are investigated only upon customer request,” FDA says.
In another repeat violation from the 2016 inspection, FDA says the company failed to confirm system suitability testing for its analytical instruments.
Bedfont Scientific
FDA’s warning letter to Bedfont Scientific follows an inspection of the company’s Maidstone, Kent, UK facility in October 2019 that identified issues with the company’s procedures for validating the design of its ToxCo carbon monoxide breath analyzer, corrective and preventive action (CAPA) procedures, product controls and equipment validation practices.
According to FDA, the company performed design validation for the ToxCo device “on units that were not initial production units,” that included earlier firmware versions than what was implemented without documenting how the devices in the validation study are equivalent to the production units.
FDA also says the company’s “analysis of quality data is inadequate,” pointing to issues with the company’s ticket system and instances where tickets were closed without verifying CAPA effectiveness.
Philosys
In its warning letter to South Korean medical device maker Philosys, FDA says the company’s self-monitoring blood glucose test systems are misbranded due to medical device reporting issues following an inspection in August 2018.
In one case, FDA says the company failed to submit a medical device report for an event cited in a complaint that “reasonably suggests that a diabetic patient who takes prescription Lantus insulin experienced an injury … as a result of a malfunction (i.e. false high glucose readings) of your firm’s Gmate VOICE blood glucose monitoring system.” While the company submitted an MDR report for the complaint, the agency says it has not received an MDR corresponding to that specific event.
FDA also says it observed other nonconformances related to process change validation and electronic report submission but is “not pursuing further regulatory action on these objectionable conditions at this time.”
University of Kentucky
In its warning letter to University of Kentucky, FDA documents issues identified by its Office of Bioresearch Monitoring Operations (OBIMO) stemming from a November 2019 review of a nonclinical study of Fresenius Medical Care’s Novalung System conducted at a university lab.
FDA says the study director “did not ensure that all experimental data were accurately recorded and verified; did not ensure that all applicable [good laboratory practice] regulations were followed … did not ensure that raw data, specimens, and records were transferred to the archives for the nonclinical study; and did not ensure that the protocol was adequately followed.”
The agency points to three specific areas where failures occurred, including missing or incorrectly completed returned goods authorization forms; improperly managed study data and specimens; and a protocol mix-up.
FDA also cites the university lab for quality assurance issues, including failing to maintain a copy of a master schedule sheet, as well as for inaccurate and missing data in the final study report.