FDA 483 - Unknown Company - January 31, 2003

On October 26, 2023, the FDA issued a Form 483 to the University of Illinois at Urbana-Champaign following an inspection. The inspection revealed significant deviations from current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.

**Observation 1:** The university's drug product, **[Redacted Drug Name]**, was manufactured without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This violates Section 505(a) of the Federal Food, Drug, and Cosmetic Act, which requires FDA approval for new drugs before interstate commerce.

**Observation 2:** The facility failed to establish and follow adequate written procedures for production and process control. Specifically, there was no master batch record for **[Redacted Drug Name]**, and no written procedures for equipment cleaning, maintenance, or calibration. This is a violation of 21 CFR 211.100(a) and 21 CFR 211.182.

**Observation 3:** The university lacked a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. This violates 21 CFR 211.22(a).

**Observation 4:** There was no written stability testing program to assess the stability characteristics of **[Redacted Drug Name