# FDA 483 - Covance Laboratories, Inc. - November 02, 2000

Source: https://www.keypedia.com/records/483/covance-laboratories-inc/2e8b1fa0-4083-4576-b685-ff1c81951f08

> FDA 483 for Covance Laboratories, Inc. on November 02, 2000. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covance Laboratories, Inc.
- Inspection Date: 2000-11-02
- Product Type: other
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Covance Laboratories, Inc. in Vienna, VA, a non-clinical laboratory, revealed significant issues related to study conduct and data integrity. Observations included the failure to review clinical history records, leading to the inclusion of Hepatitis A positive animals in a study, and inaccuracies in the final report regarding animal testing. Additionally, the firm failed to include dosage formulation analyses in a final report and exhibited poor record-keeping for protocol amendments and equipment documentation.

## Related Documents

- [483 - 2000-07-12](https://www.keypedia.com/records/483/covance-laboratories-inc/e8e4708c-505e-474c-9b3f-1032cb5afd3c)
- [EIR - 2001-01-11](https://www.keypedia.com/records/eir/covance-laboratories-inc/6acc728d-561a-4ce2-8e67-88ada1a264d2)

## Related Officers

- [Lynette P. Salisbury, CSO](https://www.keypedia.com/people/lynette-p-salisbury-cso/2381c97a-334b-403b-8347-0eead6a69f60)
- [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