Toxikon Corporation/Labcorp Bedford LLC

Warning LetterClosed

Laxman S. Desai, D.Sc. Toxikon Corporation/Labcorp Bedford LLC 15 Wiggins Avenue Bedford , MA 01730-2314 United StatesIssued Feb 10, 2022Center for Biologics Evaluation and Research

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateFeb 10, 2022

Product TypeOther

StatusClosed

Closeout LetterNov 2, 2022

Letter Details

Firm: Toxikon Corporation/Labcorp Bedford LLC
Location: Laxman S. Desai, D.Sc. Toxikon Corporation/Labcorp Bedford LLC 15 Wiggins Avenue Bedford , MA 01730-2314 United States
FEI Number: N/A
Country: United States
Issue Date: February 10, 2022
Issuing Office: Center for Biologics Evaluation and Research
Product Type: Other
Status: Closed
Closeout Letter: November 02, 2022

Summary

Toxikon Corporation/Labcorp Bedford LLC, a biologics testing laboratory, failed to comply with Good Laboratory Practice (GLP) regulations during a nonclinical study inspection conducted between August and September 2021. The company violated 21 CFR Part 58 requirements, specifically failing to ensure that all experimental data and unanticipated test system responses were accurately recorded and verified, with the study director not maintaining adequate control and documentation of the study conduct. The inspection was conducted under the FDA's Bioresearch Monitoring Program to verify the scientific validity and accuracy of nonclinical research data for investigational products.

Toxikon Corporation/Labcorp Bedford LLC FDA Warning Letter, February 10, 2022