# FDA 483 - LabAnalysis Life Science S.R.L. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/labanalysis-life-science-srl/61b5f9c9-ad50-406a-8a6f-feb2701249d8

> FDA 483 for LabAnalysis Life Science S.R.L. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LabAnalysis Life Science S.R.L.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: LabAnalysis S.r.l. in Casanova Lonati, Pavia, Italy, was inspected by the FDA from October 23-27, 2023, and received a Form 483 with two observations. The inspection revealed deficiencies related to the retention of reference listed drug reserve samples and the incomplete documentation of analytical results in study reports submitted to the FDA. These issues indicate concerns with laboratory controls and data integrity in their biopharmaceutical analytical facility.

## Related Officers

- [Ruben C. Ayala, PharmD, Lead Pharmacokineticist](https://www.globalkeysolutions.net/people/ruben-c-ayala-pharmd-lead-pharmacokineticist/7f55123e-b6ff-41bb-9865-98357aab636a)
- [issuing_officer](https://www.globalkeysolutions.net/people/sri-rama-krishnaiah-yellela/9cf2e148-03b3-4e6a-b878-6dee15f651a6)

Company: https://www.globalkeysolutions.net/companies/labanalysis-life-science-srl/b81481c5-b10d-4391-81ce-f9a09f554992

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd