Stokes Healthcare Inc. dba Epicur Pharma – FDA 483, Oct 9, 2020

This FDA Form 483 document details observations from an inspection, citing several deviations from regulatory requirements for drug product manufacturing. The facility, operating cleanroom C704 with a new ophthalmic bottle filling line, was found to have multiple issues.

One observation notes a deviation from written production and process control procedures. Specifically, during a media fill (b)(4) performed in June 2020 to validate aseptic processing, units dropped or knocked to the floor after visual inspection were not investigated or justified for not being incubated for the balance of the (b)(4) and then inspected for turbidity/microbial growth.

Another critical finding is the lack of written procedures for production and process controls to assure drug product identity, strength, quality, and purity. The firm lacks process control validation data for filling ophthalmic drug products into 8ml and 4ml plastic bottles. Existing validation data from 15ml bottles does not correlate with the (b)(4) operating at (b)(4). Missing data includes line speed correlation to downtime, number of interventions in the ISO 5 area, and the firm's ability to maintain aseptic conditions.

Furthermore, procedures for handling all written and oral complaints regarding drug products are not established and followed. Seven product complaints (20-007 to 20-013) received between March 10, 2020, and September 23, 2020,