# FDA 483 - Pillar5 Pharma Inc. - February 07, 2025

Source: https://www.globalkeysolutions.net/records/483/pillar5-pharma-inc/aae128df-7323-4546-9ab7-cb02e0d26682

> FDA 483 for Pillar5 Pharma Inc. on February 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pillar5 Pharma Inc.
- Inspection Date: 2025-02-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Pillar5 Pharma Inc., a contract manufacturer in Arnprior, was cited for significant deficiencies in its aseptic processing, quality control, and laboratory operations. The inspection revealed inadequate validation of aseptic processes, poor disinfectant efficacy studies, and failures in thoroughly investigating discrepancies and maintaining stability programs. These issues raise concerns about the sterility assurance and overall quality of drug products manufactured by the firm.

## Related Documents

- [483 - 2020-02-21](https://www.globalkeysolutions.net/records/483/pillar5-pharma-inc/3fef87a0-f16d-4de4-bd43-7132bce6c38f)
- [483 - 2023-12-15](https://www.globalkeysolutions.net/records/483/pillar5-pharma-inc/49d12328-3ebf-4ca3-ade2-5b08703919fb)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Miguel A. Martinez](https://www.globalkeysolutions.net/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)

Company: https://www.globalkeysolutions.net/companies/pillar5-pharma-inc/8b94b834-f2da-4821-9ddc-6795a5e6d6f0

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8