# FDA 483 - Steri-Pharma, LLC - August 08, 2025

Source: https://www.globalkeysolutions.net/records/483/steri-pharma-llc/cec013e8-5afc-4d97-aca2-5e442b76b08d

> FDA 483 for Steri-Pharma, LLC on August 08, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steri-Pharma, LLC
- Inspection Date: 2025-08-08
- Product Type: drugs
- Office Name: New York District Office
- Summary: Steri-Pharma, LLC in Syracuse, NY, was inspected and cited for significant deficiencies across three observations. The inspection revealed inadequate written procedures for production and process controls, particularly concerning process validation studies for drug products. Additionally, the firm failed to adequately validate its aseptic processes and did not thoroughly review unexplained discrepancies, including repeated mold recoveries in aseptic processing areas.

## Related Documents

- [483 - 2022-10-04](https://www.globalkeysolutions.net/records/483/steri-pharma-llc/bcefd166-90f4-4345-a237-cccc9f40a479)

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Robin P. Mathew](https://www.globalkeysolutions.net/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)

Company: https://www.globalkeysolutions.net/companies/steri-pharma-llc/dc07f20b-6149-4c5e-94e0-2a518415a5c1

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d