# FDA 483 - Covance Laboratories, Inc. - July 12, 2000

Source: https://www.keypedia.com/records/483/covance-laboratories-inc/e8e4708c-505e-474c-9b3f-1032cb5afd3c

> FDA 483 for Covance Laboratories, Inc. on July 12, 2000. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covance Laboratories, Inc.
- Inspection Date: 2000-07-12
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: During an inspection, Covance Laboratories, Inc. in Vienna, VA, was cited for multiple failures in their nonclinical laboratory operations. Observations included inadequate handling and analysis of chemistry specimens, failure to maintain sample handling documentation, and unarchived study records. Additionally, the firm failed to follow written procedures for computer system audit trails, had conflicting blood sample records, and produced incomplete final study reports.

## Related Documents

- [483 - 2000-11-02](https://www.keypedia.com/records/483/covance-laboratories-inc/2e8b1fa0-4083-4576-b685-ff1c81951f08)
- [EIR - 2001-01-11](https://www.keypedia.com/records/eir/covance-laboratories-inc/6acc728d-561a-4ce2-8e67-88ada1a264d2)

## Related Officers

- [Investigator at US FDA](https://www.keypedia.com/people/jacqueline-a-oshaughnessy/bfe49401-ede0-47b6-9b92-597c3c237f71)

Company: https://www.keypedia.com/companies/covance-laboratories-inc/290b64f5-050b-4cf3-b52a-7e60f59a570e

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa