# FDA 483 - Primera Analytical Solutions Corp. - April 12, 2024

Source: https://www.keypedia.com/records/483/primera-analytical-solutions-corp/0402856d-01c4-4bec-b63b-65e8395eedab

> FDA 483 for Primera Analytical Solutions Corp. on April 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Primera Analytical Solutions Corp.
- Inspection Date: 2024-04-12
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Primera Analytical Solutions Corp., a control testing laboratory in Cranbury, NJ, was cited for significant deficiencies in its quality control unit. The firm failed to follow its own standard operating procedures for performing, documenting, and reviewing calculations and ensuring data integrity. Specifically, the quality unit did not verify calculations on unvalidated excel spreadsheets for method validation data and did not document data review for an ANDA.

## Related Documents

- [483 - 2018-11-20](https://www.keypedia.com/records/483/primera-analytical-solutions-corp/04189749-55ce-49a3-b72f-a904e1f30816)
- [483 - Unknown Date](https://www.keypedia.com/records/483/primera-analytical-solutions-corp/ed215f37-bd89-45eb-a6e5-0390694749b2)

## Related Officers

- [Alisha B. Patel](https://www.keypedia.com/people/alisha-b-patel/3c106dac-0e0d-41f2-9f7a-69982d4e6579)
- [Elena N. Thomas](https://www.keypedia.com/people/elena-n-thomas/80a975fe-c475-447e-9471-dedb68a99aae)
- [investigator](https://www.keypedia.com/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)
- [investigator](https://www.keypedia.com/people/ifechimere-i-okafor/c48399bf-47d9-4562-9130-1e6731eca07d)

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

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248