# FDA 483 - Pillar5 Pharma Inc. - February 21, 2020

Source: https://www.globalkeysolutions.net/records/483/pillar5-pharma-inc/3fef87a0-f16d-4de4-bd43-7132bce6c38f

> FDA 483 for Pillar5 Pharma Inc. on February 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pillar5 Pharma Inc.
- Inspection Date: 2020-02-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Pillar5 Pharma Inc. in Arnprior, Ontario, was cited by the FDA for failing to establish adequate procedures to prevent microbiological contamination of sterile drug products. The inspection revealed deficiencies in the media fill program's simulation of routine interventions and a lack of required cleaning protocols for aseptic processing interventions. These findings indicate significant concerns regarding the sterility assurance of their manufactured products.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1