FDA 483 - IntegraDose Compounding Services LLC - July 25, 2025

**FDA 483 Summary for IntegraDose Compounding Services LLC**

**Inspection Details:** - **Company Name:** IntegraDose Compounding Services LLC - **Inspection Dates:** July 15, 2025 - July 25, 2025 - **Location:** Minneapolis, MN - **Type of Establishment:** Outsourcing Facility

**Key Violations:** 1. **Microbiological Contamination Prevention:** Procedures to prevent contamination in sterile drug products are not adequately documented or followed. This includes poor aseptic techniques observed during the production of Fentanyl Citrate and Oxytocin, such as improper handling of vials and inadequate environmental controls.

2. **Quality Control Criteria:** The statistical quality control criteria for visual inspections are insufficient. The acceptance limits for reinspection are not scientifically justified, leading to the release of batches with critical defects that were not addressed during initial inspections.

3. **Employee Training:** Employees lack adequate training for their roles, particularly in visual inspection processes. The firm does not maintain a comprehensive library of defects for training, and current qualification processes do not simulate real-world inspection conditions.

4. **Aseptic Processing Areas:** Deficiencies in maintaining aseptic conditions were noted, including the use of unevaluated smoke sources for dynamic smoke studies and inadequate visualization in study videos.

5. **Laboratory Records:** Laboratory records lack a second-person verification for accuracy, particularly in environmental monitoring plate readings.

6. **Quality Control Unit Responsibilities:** The quality control unit does not fully oversee the approval of procedures or specifications impacting product quality.

**Regulatory Framework and Required Actions:** The observations are based on compliance with FDA regulations governing drug manufacturing practices. IntegraDose is required to address these deficiencies by implementing corrective actions, such as revising procedures, enhancing employee training, improving aseptic processing controls, and ensuring robust quality control measures. Failure to address these issues may result in further regulatory actions. The company is encouraged to discuss objections or corrective actions with