# FDA 483 - Pine Pharmaceuticals, LLC - September 30, 2024

Source: https://www.keypedia.com/records/483/pine-pharmaceuticals-llc/a36994ea-3c8c-4ee3-8f80-79285e187482

> FDA 483 for Pine Pharmaceuticals, LLC on September 30, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pine Pharmaceuticals, LLC
- Inspection Date: 2024-09-30
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: This FDA Form 483, issued to Pine Pharmaceuticals, LLC, an outsourcing facility in Tonawanda, NY, following an inspection from August 5 to September 30, 2024, details nine observations of objectionable conditions.

**Key Violations and Observations:**

1.  **Aseptic Processing Area Deficiencies (Air Supply):**
    *   Open sterile product bottles were moved through non-HEPA filtered areas during Lidocaine HCL 4% Ophthalmic Solution production.
    *   Lack of environmental monitoring in a critical transfer area.
    *   Smoke study revealed turbulent airflow from capping to filling areas, increasing particulate risk.
    *   Inadequate justification for air velocity and airflow patterns in laminar flow hoods (e.g., Hood (b)(4) 85-189 FPM, Hood (b)(4) 38-145 FPM).
    *   Airflow visualization studies were insufficient, not performed under dynamic conditions, showed turbulent air, and smoke probe positioning was inadequate.
    *   Dynamic smoke study from 9/14/23 was inadequate due to ISO 7 buffer room airflow concerns, a **repeated observation from 09/2023**.
    *   Operators exhibited inadequate aseptic technique, including resting arms on ISO 5 hoods, working outside the hood, and product placement at the hood edge, a **repeated observation from

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## Related Officers

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Company: https://www.keypedia.com/companies/pine-pharmaceuticals-llc/03870efc-b074-462a-8520-e5cadc945149

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861