FDA EIR - SHL Pharma LLC - January 29, 2019

An FDA inspection of SHL Pharma LLC, a drug assembler and packager in Deerfield Beach, FL, was conducted from January 22-29, 2019. The inspection covered general drug manufacturing practices under Compliance Program 7356.002 and a pre-approval assessment for Biologic License Application (BLA) 761118 (Abrilada), a combination biopharmaceutical device product, under Compliance Program 7346.832. The regulatory framework for this oversight falls under the Federal Food, Drug & Cosmetic Act. Although no Form FDA 483 (Inspectional Observations) was issued, several verbal observations were discussed with management. Key issues included the need to secure all labeling, including secondary packaging with product information, which was corrected during the inspection. Additionally, the firm was advised to verify computer-generated printout data with electronic source data before making manufacturing decisions and to ensure assembly line sensors making critical decisions are regularly challenged and documented in batch records. A concern was also raised regarding the communication of potential complaints related to device sterility breaches from product owners to SHL Pharma. The Managing Director committed to addressing these observations to ensure full compliance and prevent potential future regulatory findings.