# FDA 483 - PharmaLegacy Research LLC - July 08, 2022

Source: https://www.globalkeysolutions.net/records/483/pharmalegacy-research-llc/9fec7ac8-3afc-4f5a-a0d3-7911b8625966

> FDA 483 for PharmaLegacy Research LLC on July 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PharmaLegacy Research LLC
- Inspection Date: 2022-07-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Samm Solutions, Inc (dba) BTS Research, a GLP Facility/CRO in San Diego, CA, revealed significant deficiencies in the conduct and documentation of nonclinical laboratory studies. The firm failed to adhere to study protocols, maintain adequate standard operating procedures, and ensure proper oversight by study directors and the quality assurance unit. These systemic issues compromised data integrity, led to inaccurate final reports, and resulted in disorganized archiving practices.

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## Related Officers

- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.globalkeysolutions.net/companies/pharmalegacy-research-llc/bdd63a11-ccc9-46b9-892e-e7f7548ef0a9

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