# FDA 483 - INVITRO RESEARCH SOLUTIONS PRIVATE LIMITED - December 18, 2025

Source: https://www.keypedia.com/records/483/invitro-research-solutions-private-limited/06b5c7f0-b3e0-414b-81b4-940b1bc989b5

> FDA 483 for INVITRO RESEARCH SOLUTIONS PRIVATE LIMITED on December 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: INVITRO RESEARCH SOLUTIONS PRIVATE LIMITED
- Inspection Date: 2025-12-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Invitro Research Solutions Private Ltd, a control testing laboratory in Bengaluru, India, was cited for significant deficiencies in its laboratory controls and quality systems. Observations included incomplete laboratory records for method validation, inadequate investigations into failed analyses, and a lack of sufficiently detailed written procedures for various production and process controls. The firm also failed to demonstrate the specificity of its in-house method for analyzing stability samples.

## Related Documents

- [483 - 2025-12-18](https://www.keypedia.com/records/483/invitro-research-solutions-private-limited/8f72bc4a-3ce2-4bb8-8ea6-30753e823570)

## Related Officers

- [Pharmaceutical Program Expert](https://www.keypedia.com/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)

Company: https://www.keypedia.com/companies/invitro-research-solutions-private-limited/4515ddf8-2183-469d-a1c6-fc21bdd267b1

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