FDA 483_RESPONSE - N-Molecular Inc. d.b.a. SOFIE - November 07, 2024

**FDA 483 Response Summary: SOFIE**

**Company:** N-Molecular Inc. dba SOFIE **Inspection Dates:** November 7-9, 2024 **Location:** Haverhill, MA facility **FEI Number:** 3005693151

**Main Violations/Issues:**

1. **Batch Production Records:** SOFIE's batch production records did not include original testing results and calculations necessary for critical release tests of PET drug products. Specifically, there was a failure to document the conversion of gauge readings from one unit to another, which is inconsistent with Current Good Manufacturing Practice (CGMP) standards.

2. **Quality Assurance Procedures:** SOFIE did not consistently follow written quality assurance procedures, particularly regarding the disinfection of materials transferred into critical ISO-5 aseptic production areas. Instances were observed where materials were not disinfected as required when moved between different cleanroom environments.

**Regulatory Framework:** The issues identified fall under the regulatory framework of CGMP, which ensures the quality and safety of pharmaceutical products.

**Required Actions:**

- **Immediate Corrective Actions:** SOFIE initiated corrective actions, including retraining staff on proper conversion methods and replacing the gauge with one that reports in the required units. A survey confirmed compliance across all SOFIE sites.

- **Long-term Corrective Actions:** A retrospective review of released batches will assess potential impacts. SOFIE plans to update documentation practices and provide comprehensive training on these updates. The completion of these actions is scheduled for early 2025.

- **Quality Assurance Improvements:** SOFIE committed to revising and enforcing its quality assurance procedures to ensure compliance with disinfection protocols.

SOFIE has expressed its commitment to addressing these concerns and ensuring compliance with FDA regulations to maintain high-quality standards in its radiopharmaceutical production.