# FDA EIR - Huntingdon Life Sciences, Inc. - August 14, 2020

Source: https://www.keypedia.com/records/eir/huntingdon-life-sciences-inc/e4c708f6-2ac9-4e8b-a73d-28277c204c16

> FDA EIR for Huntingdon Life Sciences, Inc. on August 14, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Huntingdon Life Sciences, Inc.
- Inspection Date: 2020-08-14
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA surveillance inspection of Covance Laboratories, Inc., located in Somerset, NJ, was conducted from August 6 to August 14, 2020. This inspection focused on the non-clinical laboratory testing facility, guided by Good Laboratory Practice (GLP) regulations (CP 7348.808). Unlike a previous inspection in 2017, which identified significant issues such as failure to issue final reports for studies, non-compliance with protocols, and inadequate documentation of deviations, the current inspection concluded without the issuance of a Form FDA-483 (Inspectional Observations). The comprehensive review covered areas including the master schedule, personnel, quality assurance, equipment, and study execution. During a general discussion with management, the firm was reminded of two minor operational points: ensuring proper disposal of test articles and preventing test articles from entering the control processing room. While a written response was not formally required, Covance Laboratories voluntarily committed to providing one. The FDA's recommendation for this inspection is "No Action Indicated" (NAI), pending final classification by CDER, signifying a satisfactory compliance status at the time of the inspection regarding the regulatory framework for non-clinical laboratories.

## Related Documents

- [483 - 2011-01-28](https://www.keypedia.com/records/483/huntingdon-life-sciences-inc/7e6a4ec9-f410-4555-81ff-b781b58cd1f5)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/zhou-chen/03362438-eba1-4010-b6b1-5cccf25a824c)
- [other](https://www.keypedia.com/people/angel-s-johnson/2c3ebf98-c05b-418d-92c3-dc49feca8f37)
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- [other](https://www.keypedia.com/people/c-smith/8eae8351-6fe3-44cb-b0d0-6afd62754108)
- [Regulatory Officer](https://www.keypedia.com/people/peter-r-lenahan/c695dac2-5447-434b-801e-f95e6acf05f1)

Company: https://www.keypedia.com/companies/huntingdon-life-sciences-inc/9ecc5f63-db36-4fcf-9f39-654bbcb8d8de

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c