# East Tennessee Clinical Research, Inc – FDA 483, Oct 21, 2014

Source: https://www.keypedia.com/records/483/east-tennessee-clinical-research-inc/80eaa7da-a08e-461a-bf6b-e3108b0efb50

> FDA 483 for East Tennessee Clinical Research, Inc on October 21, 2014. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: East Tennessee Clinical Research, Inc
- Inspection Date: 2014-10-21
- Product Type: other
- Office Name: New Orleans District Office
- Summary: An FDA inspection of East Tennessee Clinical Research, Inc. in Rockwood, TN, a non-clinical laboratory, revealed significant deficiencies in its adherence to Good Laboratory Practices. Observations included failures in determining stability and characterizing study articles, inadequate quality assurance unit oversight, and insufficient personnel training. The firm also failed to properly document final study reports, indicating systemic issues in study integrity and record-keeping.

## Related Documents

- [483 - 2023-05-26](https://www.keypedia.com/records/483/east-tennessee-clinical-research-inc/f5ce4e11-3e57-4ddf-b2f6-5992a8f4df47) — date: May 26, 2023
- [EIR - 2014-10-21](https://www.keypedia.com/records/eir/east-tennessee-clinical-research-inc/b77e7ea6-ae8a-4dd3-af48-cae26c008641) — date: October 21, 2014
- [EIR - 2012-05-29](https://www.keypedia.com/records/eir/east-tennessee-clinical-research-inc/3e249c10-6792-4276-bdb7-c925b951048b) — date: May 29, 2012

## Related Officers

- [investigator](https://www.keypedia.com/people/ann-b-borromeo/ca03a531-043c-4195-b100-a8a0fc763159)

Company: https://www.keypedia.com/companies/east-tennessee-clinical-research-inc/d7ac5584-af1a-448a-8edf-dd487a22fe4a

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea