FDA 483 - Pine Pharmaceuticals, LLC - November 04, 2025

During an inspection conducted from November 4 to November 14, 2025, the U.S. Food and Drug Administration (FDA) observed significant deficiencies at Pine Pharmaceuticals, LLC, an outsourcing facility located in Tonawanda, NY. The inspection identified two primary violations of current Good Manufacturing Practices (cGMP) related to quality control and aseptic processing.

Observation 1 highlighted a systemic failure to thoroughly review unexplained discrepancies, particularly concerning the release of sterile drug products with confirmed defects. Examples included the release of Vancomycin vials despite a customer complaint confirming visible particulates (cellulose and unidentified fibers), with no subsequent corrective actions or identification of the fibers. The firm also repeatedly released other sterile drug products, such as Bevacizumab and Moxifloxacin, even after initial inspections revealed high critical defect rates, including container closure integrity issues and partially crimped seals. In these cases, the company relied on re-inspections and removal of identified defective units without fully resolving or scientifically justifying the overall quality of the batches.

Observation 2 detailed a failure to adhere to established procedures designed to prevent microbiological contamination during aseptic manufacturing. Inspectors observed operators engaging in poor aseptic techniques, such as extending unsanitized arms and sleeves into ISO critical zones and failing to sanitize transfer tubing or hands upon entry into sterile areas.

As an FDA 483, this document mandates Pine Pharmaceuticals, LLC to promptly investigate these observations, implement comprehensive corrective and preventive actions, and demonstrate compliance with cGMP to ensure the safety, quality, and sterility of their compounded sterile drug products.