The Ohio-headquartered contract research organisation (CRO) offers regulatory, laboratory, clinical, and compliance services from its global network.
From November 1 to 17, 2017, a US Food and Drug Administration (FDA) inspector flagged a number of good laboratory practice (GLP) violations, including inadequate identification of study specimens.
According to the heavily redacted warning letter, a number of specimen containers had not been classified by study, type, or date of collection, and other samples had been identified – with handwritten notes adhered to containers – as missing or unaccounted for. “This issue raises questions regarding your firm’s ability to maintain the integrity and reliability of study data,” wrote the FDA.
In addition, the investigator observed that specimens were stored in a tissue and supply closet, rather than in a designated archive, prompting the FDA to comment: “Incorrect archiving of study materials affects the integrity and reliability of study data as it prevents accurate retrieval of such data for review, analysis, and verification.”
NAMSA’s study director had also failed to ensure experimental data were recorded and verified, and that “unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study were noted when they occurred, and corrective action was taken and documented,” according to the agency.
The FDA requested a conference call with the CRO, to “discuss the concerns and provide guidance for future non-clinical studies involving FDA regulated devices that you will conduct.”
NAMSA: ‘We look forward to resolving this situation’
The CRO has responded to the FDA’s warning letter, highlighting its commitment to partners and sponsors.
“NAMSA recognizes the significance of US FDA observations and as such, has been involved in ongoing and transparent conversations with the FDA in order to remediate these matters,” commented President and CEO John Gorski.
“The FDA has acknowledged our corrective and preventive actions, and NAMSA continues to work with them to ensure the documentation of the systemic changes fulfils FDA requests. We look forward to resolving this situation and applying best practices learned to all NAMSA global facilities.
“NAMSA remains committed to delivering superior client results and assisting sponsors in the safe and efficacious development of life-saving medical technologies,” Gorski concluded.
