# FDA 483 - Intact Pharmaceuticals LLC - October 12, 2018

Source: https://www.keypedia.com/records/483/intact-pharmaceuticals-llc/a7f4cd95-dde1-440c-a209-59cf274c93cd

> FDA 483 for Intact Pharmaceuticals LLC on October 12, 2018. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Intact Pharmaceuticals LLC
- Inspection Date: 2018-10-12
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspection of a facility producing 0.9% Sodium Chloride Solution for Injection revealed eleven observations.

**Facility and Operations:** The aseptic filling of 0.9% Sodium Chloride Solution for Injection occurs in a controlled, non-classified (CNC) environment, not the required ISO 5, with surrounding areas not classified to ISO 7.

**Violations and Observations:**

*   **Aseptic Processing Area Deficiencies (Observation 1):** The facility lacks adequate controls for maintaining aseptic conditions. HEPA filters are not certified or periodically leak-tested, and air velocity specifications are absent. Airflow patterns were not directly tested, and studies showed turbulent airflow, failing to provide first-pass air over critical areas. Documentation for airflow studies was lacking, and HEPA filter performance over their lifecycle was not adequately managed, including a lack of decommissioning plans. A crack was observed in equipment intended to reduce operator and particulate contact.
*   **Environmental Monitoring Deficiencies (Observation 2):** Routine environmental monitoring for total particle counts, surface, and airborne viable sampling is not performed in filling rooms, equipment interiors, or ISO 8 formulation areas. Differential pressure between CNC and non-classified areas is not monitored.
*   **Aseptic Process Validation Deficiencies (Observation 3):** The aseptic process was not adequately validated. Test equipment lacked dedicated logs, preventive maintenance, and validated test methods. A deviation during validation involving incorrect equipment was not evaluated for its impact

## Related Officers

- [Microbiologist](https://www.keypedia.com/people/djamila-harouaka/106cef03-a214-4184-963a-6580d3bd7fd9)
- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

Company: https://www.keypedia.com/companies/intact-pharmaceuticals-llc/e75fb689-3d7a-43a8-b3aa-d34ca1c50296

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c