483
Long Grove Pharmaceuticals LLCFDA 483 - Long Grove Pharmaceuticals LLC - November 06, 2024
Record Details
Long Grove Pharmaceuticals, LLC, an application holder and distributor for drug products, was cited for significant deficiencies during an FDA inspection. The firm lacks a functional quality control unit, written procedures for quality unit responsibilities, and failed to adequately investigate a complaint regarding potential bacterial contamination in a distributed drug product. These observations indicate serious non-compliance with regulatory requirements.
Open in Dashboard
ID · b3f64c36-e62e-4432-94e6-f1cf0304baf2