# FDA 483 - BioPort Corporation - October 26, 2000

Source: https://www.globalkeysolutions.net/records/483/bioport-corporation/65d5e0bb-fc88-499d-8c31-9f9ddf9bd60a

> FDA 483 for BioPort Corporation on October 26, 2000. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioPort Corporation
- Inspection Date: 2000-10-26
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: This FDA Form 483 details numerous observations regarding sterility assurance, quality systems, and manufacturing processes at the facility.

**Facility and Operations:** The inspection focused on the filling suite (Rms [redacted]), gowning room ([redacted]), capping area, and related equipment like hot air ovens and autoclaves. Products mentioned include Albumin, Anthrax Vaccine, and Rabies Vaccine.

**Violations and Observations:**

*   **Sterility Assurance (Observation 1):**
    *   **Design/Construction:** Unsealed seams around the hot air oven allowed smoke ingress from unclassified areas. Floors in Room [redacted] were not easily cleanable, and walls had seams. A vinyl curtain separating Class 10,000 from Class 100 areas was too high, discolored, taped, and allowed smoke ingress. The in-line HEPA filter for the hot air oven was in a Class 10,000 area. The gowning room lacked an air return. Rust was observed on oven hinges, floor, and HEPA filter grates. Temperature/humidity specifications for Room [redacted] were not met when the oven operated. Smoke studies showed turbulence near the gowning room exit and non-uniform air return.
    *   **Gowning Room Airlock (Observation 11):** Interlocking doors had an override, and the SOP did not address proper airlock use.
    *

## Related Officers

- [Robert E. Garrett](https://www.globalkeysolutions.net/people/robert-e-garrett/11939023-f42b-4574-8da3-bfdba59f1f57)

Company: https://www.globalkeysolutions.net/companies/bioport-corporation/944b277c-b406-4571-8278-c06de381bbe9

Office: https://www.globalkeysolutions.net/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d