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

Source: https://www.globalkeysolutions.net/records/483/primera-analytical-solutions-corp/ed215f37-bd89-45eb-a6e5-0390694749b2

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

---

## Details

- Record Type: 483
- Company Name: Primera Analytical Solutions Corp.
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Primera Analytical Solutions Corporation, an analytical testing facility in Cranbury, NJ, was inspected by the FDA from October 24-28, 2022. The inspection revealed that during validation, a method to measure (b) (4) levels for kinetic binding studies did not meet the firm's established acceptance criteria. This indicates a deficiency in their analytical method validation processes.

## Related Documents

- [483 - 2018-11-20](https://www.globalkeysolutions.net/records/483/primera-analytical-solutions-corp/04189749-55ce-49a3-b72f-a904e1f30816)
- [483 - 2024-04-12](https://www.globalkeysolutions.net/records/483/primera-analytical-solutions-corp/0402856d-01c4-4bec-b63b-65e8395eedab)

## Related Officers

- [Sripal Reddy Mada, Ph.D., Pharmacologist](https://www.globalkeysolutions.net/people/sripal-reddy-mada-phd-pharmacologist/25f108fd-2140-46cf-9ba0-9c1968b463a5)

Company: https://www.globalkeysolutions.net/companies/primera-analytical-solutions-corp/ebb79960-5890-48cc-a980-6b7cfe02aad4

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321