CRO’s Improper Specimen Storage Draws FDA Warning
Posted 15 August 2018 | By
An international contract research organization (CRO) drew a warning letter from the US Food and Drug Administration (FDA) based on an inspection that revealed violations of good laboratory practices (GLP), including the storage of specimens in “a tissue and supply closet.”
The FDA’s inspection of North American Science Associates (NAMSA), which provides regulatory consulting, laboratory testing and clinical research services to the medical device industry, was conducted in November 2017 to inspect compliance to GLP for nonclinical studies.
The CRO’s services to industry are commonly used in support of premarket submissions to FDA’s Center for Devices and Radiological Health (CDRH). NAMSA has also previously received FDA clearance for at least one medical device
—the Biological Indicator Spore Strips.
“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,” President and CEO John Gorski told Focus
. “The FDA has acknowledged our corrective and preventive actions, and NAMSA continues to work with them to ensure the documentation of the systemic changes fulfills FDA requests. We look forward to resolving this situation and applying best practices learned to all NAMSA global facilities.”
CDRH cited the firm for four GLP violations after the firm’s December 2017 response to the Form 483 inspectional violations “appears to be incomplete.” These include two GLP violations with regards to inadequate handling of study specimens.
Specimens produced in seven different studies had not been properly handled as the agency investigator revealed these had been stored outside of the firm’s archive and in the closet.
“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,” said William Maisel, acting director at CDRH’s Office of Compliance. “Failure to have an index prevents data from being readily available, located expeditiously, analyzed, and reconciled when necessary.”
The firm’s response indicated that an SOP received updates to clarify the archiving process and requirements, as well as the appropriate locations for storing specimens. But it was insufficient in that no training requirements to prevent recurrence were identified, according to CDRH.
The agency investigator also revealed that “numerous specimen containers had hand written notes adhered to their exterior identifying that samples were unaccounted for or missing.” There were also specimens for seven studies that had not been properly identified to prevent mix-ups.
“This raises concerns regarding the reliability and accuracy of the test results,” Maisel said.
As part of its response, the firm reported it had conducted training and relabeled specimens in accordance with the required additional labeling information under a revised SOP. Yet it did not describe how the specimens had been located and relabeled without traceable information.
Further, reagents and solutions in the firm’s laboratory had been lacking concentration, storage requirements and expiration dates at the time of the FDA site inspection. This “raises concerns regarding reliability and accuracy of the test results” because the “lack of adequate labeling poses a risk of using the wrong reagent or solution,” Maisel added.