# FDA 483 - ARL Biopharma, Inc. dba Analytical Research Laboratories - September 05, 2019

Source: https://www.globalkeysolutions.net/records/483/arl-biopharma-inc-dba-analytical-research-laboratories/4e19e914-ce9d-4342-96dc-f564f8420248

> FDA 483 for ARL Biopharma, Inc. dba Analytical Research Laboratories on September 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARL Biopharma, Inc. dba Analytical Research Laboratories
- Inspection Date: 2019-09-05
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Alc Biopharma Inc., a contract testing laboratory in Oklahoma City, was cited for significant data integrity issues during an FDA inspection. The firm failed to implement proper controls for electronic laboratory equipment, including a lack of unique user access and an absence of audit trail features for HPLC software. These deficiencies raise concerns about the reliability and traceability of electronic raw data.

## Related Documents

- [483 - 2012-11-08](https://www.globalkeysolutions.net/records/483/arl-biopharma-inc-dba-analytical-research-laboratories/6ca790e1-4e13-4b6a-91b5-960aa9cd8387)

## Related Officers

- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.globalkeysolutions.net/companies/arl-biopharma-inc-dba-analytical-research-laboratories/358f0af9-fe47-4cd8-b43e-a4b9eacf1b21

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9