# FDA 483 - Primera Analytical Solutions Corp. - November 20, 2018

Source: https://www.globalkeysolutions.net/records/483/primera-analytical-solutions-corp/04189749-55ce-49a3-b72f-a904e1f30816

> FDA 483 for Primera Analytical Solutions Corp. on November 20, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Primera Analytical Solutions Corp.
- Inspection Date: 2018-11-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Primera Analytical Solutions Corp., a control testing laboratory in Cranbury, NJ, was cited for four observations related to quality system deficiencies. The inspection revealed failures in thoroughly investigating out-of-specification results, inadequate protection of electronic data from deletion, unvalidated test method calculations, and the use of unapproved documents for analytical work.

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## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)
- [James R. Birkenstamm](https://www.globalkeysolutions.net/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

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

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