# FDA 483 - Primera Analytical Solutions Corp. - Unknown Date

Source: https://www.keypedia.com/records/483/primera-analytical-solutions-corp/68f6f353-a601-49c2-b8a3-44b0f56db2cf

> FDA 483 for Primera Analytical Solutions Corp. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Primera Analytical Solutions Corp.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Pharm Analytical Solutions Corp. in Princeton, NJ, a Clinical & Bioanalytical CRO, identified four observations related to inadequate documentation and stability testing practices. The findings indicate deficiencies in the reconstruction of sample concentration rationales and the conduct of long-term stability experiments for residual drug amounts. These issues suggest potential concerns with data integrity and the reliability of analytical results.

## Related Documents

- [EIR - 2015-06-02](https://www.keypedia.com/records/eir/primera-analytical-solutions-corp/c36187a2-83c9-4d3e-969a-4ab8a1274f93)
- [EIR - 2017-01-23](https://www.keypedia.com/records/eir/primera-analytical-solutions-corp/a9ce775d-8677-4993-bed7-5cb13bc09af3)
- [483 - 2017-01-23](https://www.keypedia.com/records/483/primera-analytical-solutions-corp/0b34301c-1217-4687-b48e-1b95503793df)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/himanshu-gupta/e7b67273-e37d-47b6-b6bb-ca3758116f5d)

Company: https://www.keypedia.com/companies/primera-analytical-solutions-corp/c4729b68-8ba6-46a7-a7b8-852f38c6625f

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