FDA 483 - Pine Pharmaceuticals, LLC - April 26, 2018

This FDA Form 483 details observations from an inspection, citing deficiencies in employee training, microbiological contamination prevention, and labeling control.

Regarding employee training, the firm lacks a specific training and verification schedule for personnel involved in visual inspection of finished drug products. Although SOP #4125, "Visual Inspection – Finished Product," Version 1.1, effective 3/22/18, requires an eye exam for these personnel, no written procedures establish a requirement for color-blindness or color distinction testing. Furthermore, documentation of such eye exams for visual inspection personnel is absent.

For microbiological contamination prevention, procedures are not adequately established or followed. The Building Monitoring System, used for monitoring pressure differentials, temperatures (aseptic processing, room temperature drug storage, refrigerated/frozen drug storage, incubators), and relative humidity, has only undergone Installation Qualification (IQ) and Operational Qualification (OQ). The IQ/OQ evaluation/summary report and Performance Qualification (PQ) were not completed before system use. Additionally, the firm is not using during sterilization of goggles, stir bars, stir bar retrievers, metal instruments, and vial trays, relying solely on an for each load to indicate a °C temperature for by . Only were used for validation runs. Compounded sterile solution is reused multiple times without storage in an ISO-classified area.

Finally, strict control over labeling is not exercised. Product and container labels are generated using the firm's software and software,