# FDA 483 - Stira Pharmaceuticals LLC - November 05, 2021

Source: https://www.keypedia.com/records/483/stira-pharmaceuticals-llc/061bb232-4a42-46eb-a9ed-7fe00eec0422

> FDA 483 for Stira Pharmaceuticals LLC on November 05, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stira Pharmaceuticals LLC
- Inspection Date: 2021-11-05
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Atira Pharmaceuticals, LLC in Fairfield, NJ, a control testing laboratory, was inspected from October 27 to November 5, 2021. The inspection revealed significant deficiencies in computer system controls and software validation for laboratory equipment. These issues led to concerns regarding data integrity, as raw data files were accessible and deletable without proper audit trail capture or traceability.

## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/stira-pharmaceuticals-llc/5e44f5bb-4d18-40fa-b93c-7510e3099999

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