# Pillar5 Pharma Inc. – FDA 483, Jun 5, 2026

Source: https://www.keypedia.com/records/483/pillar5-pharma-inc/3c2f8832-59a1-4329-a5ef-379e2e12274d

> FDA 483 for Pillar5 Pharma Inc. on June 05, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pillar5 Pharma Inc.
- Inspection Date: 2026-06-05
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Pillar5 Pharma Inc. in Arnprior, a drug manufacturer, received a Form 483 citing significant deficiencies in its aseptic processing and quality control systems. The inspection revealed recurring microbiological contamination in sterile drug product manufacturing, inadequate investigations into sterility failures and environmental monitoring excursions, and incomplete batch production records. These issues indicate a high risk to product quality and patient safety, with affected batches already distributed to the U.S. market.

## Related Documents

- [483 - 2025-02-07](https://www.keypedia.com/records/483/pillar5-pharma-inc/aae128df-7323-4546-9ab7-cb02e0d26682) — date: February 7, 2025
- [483 - 2023-12-15](https://www.keypedia.com/records/483/pillar5-pharma-inc/49d12328-3ebf-4ca3-ade2-5b08703919fb) — date: December 15, 2023
- [483 - 2020-02-21](https://www.keypedia.com/records/483/pillar5-pharma-inc/3fef87a0-f16d-4de4-bd43-7132bce6c38f) — date: February 21, 2020

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)
- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)

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

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