# FDA 483 - Michelson Laboratories Inc - September 26, 2023

Source: https://www.globalkeysolutions.net/records/483/michelson-laboratories-inc/d015d6ce-ce00-4675-bf32-f27bd4c6e8c8

> FDA 483 for Michelson Laboratories Inc on September 26, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michelson Laboratories Inc
- Inspection Date: 2023-09-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Michelson Laboratories Inc, a contract manufacturing laboratory in Commerce, CA, was cited for significant deficiencies in computer system controls for HPLC machines used in pharmaceutical drug product testing. Observations included a lack of individual access controls, absence of audit trails, deletable data on local drives, and no electronic data backup. These issues indicate severe data integrity concerns regarding pharmaceutical drug product testing.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/tiara-m-brown/bbc93754-69de-4379-b9f5-f85ea4c8b0e9)

Company: https://www.globalkeysolutions.net/companies/michelson-laboratories-inc/e712d904-1bdb-4ae8-b53c-d85dc65e15e6

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6