# FDA 483 - Advanced Laboratories, Inc. - February 11, 2016

Source: https://www.keypedia.com/records/483/advanced-laboratories-inc/ec135662-c2fa-4c77-a242-2bccdf743175

> FDA 483 for Advanced Laboratories, Inc. on February 11, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Laboratories, Inc.
- Inspection Date: 2016-02-11
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Advanced Laboratories, Inc. in Clayton, NC, a contract laboratory, revealed two significant observations. The firm was cited for deficiently written or followed procedures for instrument calibration, specifically regarding balance accuracy and certified ranges. Additionally, the inspection found inadequate laboratory controls, lacking scientifically sound specifications and action limits for media monitoring, which could impact drug product quality.

## Related Officers

- [Investigator](https://www.keypedia.com/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

Company: https://www.keypedia.com/companies/advanced-laboratories-inc/6467a9f3-d802-4bef-b145-50897212cb1e

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7