FDA 483 - BioPort Corporation - October 26, 2000

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. *