FDA 483 - Lonza Biologics, Inc. - June 06, 2025

**FDA 483 Summary for Lonza Portsmouth, Inc.**

**Inspection Overview:** - **Company:** Lonza Portsmouth, Inc. - **Location:** 101 International Drive, Portsmouth, NH 03801, USA - **Inspection Dates:** June 2-6, 2025 - **Lead Inspector:** Xiujv Lu

**Main Violations/Issues:** 1. **Aseptic Processing Deficiencies:** Observations during CCTV review revealed multiple breaches in aseptic protocols for the CASGEVY drug product. Operators failed to follow gowning procedures and engaged in improper conduct within the biological safety cabinet, risking contamination.

2. **Cleaning Protocol Failures:** Cleaning operations in Grade B areas were inadequate. Staff failed to adhere to established procedures, with significant omissions in cleaning critical areas and improper handling of cleaning equipment.

3. **Documentation Irregularities:** The firm exhibited poor documentation practices, including the discovery of discarded original records and inconsistencies in batch record signatures. There was also a lack of control over spreadsheets used for tracking, leading to potential data integrity issues.

4. **HVAC System Issues:** The facility experienced repeated failures in maintaining differential pressure in critical areas, with no corrective actions or root cause analysis conducted.

**Regulatory Framework:** The observations are based on the FDA's regulations for drug product manufacturing, emphasizing Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

**Required Actions:** Lonza Portsmouth, Inc. must address these deficiencies by implementing corrective actions to ensure compliance with FDA regulations. This includes revising aseptic processing and cleaning procedures, enhancing documentation controls, and resolving HVAC system issues to prevent future occurrences. The firm is encouraged to discuss objections or corrective actions with the FDA or submit detailed plans for compliance improvements.