# FDA 483 - Labcorp Bedford LLC. - April 29, 2016

Source: https://www.globalkeysolutions.net/records/483/labcorp-bedford-llc/a91073d0-0b95-43b5-aefe-7b40d44ee24c

> FDA 483 for Labcorp Bedford LLC. on April 29, 2016. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Labcorp Bedford LLC.
- Inspection Date: 2016-04-29
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Toxikon Corporation, a non-clinical laboratory in Bedford, MA, identified issues related to the conduct and reporting of nonclinical laboratory studies. Observations included studies not being conducted according to protocol, specifically regarding test article temperature, and final study reports lacking complete personnel information. One initial observation was removed after discussion with management.

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## Related Officers

- [other](https://www.globalkeysolutions.net/people/abhijit-raha/fd6ddd19-2def-4840-bd65-98bcef15e405)
- [issuing_officer](https://www.globalkeysolutions.net/people/zhou-chen/03362438-eba1-4010-b6b1-5cccf25a824c)
- [Darin J. Mieris](https://www.globalkeysolutions.net/people/darin-j-mieris/4affcb21-ab50-4757-a60f-d4968b1b88e6)

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