# FDA 483 - Bioport Corporation - September 21, 2000

Source: https://www.keypedia.com/records/483/bioport-corporation/3ab83065-a0d9-4fb4-996e-a2533fa13d26

> FDA 483 for Bioport Corporation on September 21, 2000. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioport Corporation
- Inspection Date: 2000-09-21
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: During a September 2000 inspection, Bioport Corporation, a licensed vaccine manufacturer in Lansing, MI, was cited for multiple deficiencies related to vaccine manufacturing and reporting. Observations included inadequate procedures for adverse event reporting, improper vaccine dosing, deficient labeling procedures, and untimely submission of required reports to the FDA. The findings indicate a lack of robust quality system controls for vaccine production and post-market surveillance.

## Related Officers

- [LISA PIERCE GALES-INV.](https://www.keypedia.com/people/lisa-pierce-gales-inv/96c0a449-038d-4b1a-8530-fb690ca727b3)

Company: https://www.keypedia.com/companies/bioport-corporation/09c0ad09-a343-47a6-ae53-164a239237ed

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0