# FDA 483 - Labcorp Bedford LLC. - September 14, 2021

Source: https://www.globalkeysolutions.net/records/483/labcorp-bedford-llc/59e6a04e-073e-4ad6-979f-634d2a222d65

> FDA 483 for Labcorp Bedford LLC. on September 14, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Labcorp Bedford LLC.
- Inspection Date: 2021-09-14
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: The FDA inspected Toxikon Corporation in Bedford, MA, and found significant issues in their nonclinical laboratory studies. The study director failed to ensure accurate data recording, verification, and proper documentation of experimental data and unforeseen circumstances. Furthermore, the quality assurance unit did not adequately review final study reports, leading to the inclusion of erroneous data and incomplete descriptions of study methods and deviations.

## Related Documents

- [483 - 2016-04-29](https://www.globalkeysolutions.net/records/483/labcorp-bedford-llc/a91073d0-0b95-43b5-aefe-7b40d44ee24c)
- [483 - 2019-01-24](https://www.globalkeysolutions.net/records/483/labcorp-bedford-llc/66c0eea5-0127-48ee-ba28-861a6425e8c0)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.globalkeysolutions.net/companies/labcorp-bedford-llc/99b3d9a6-1820-4831-b652-6e11e9969fe7

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7