FDA 483 - Imprimis NJOF, LLC - April 03, 2024

The FDA Form 483 details significant deficiencies at a drug manufacturing facility. The firm failed to reject drug products with Out-of-Specification (OOS) stability results, with investigations remaining open despite closed Change Controls to shorten Beyond Use Dates without scientific rationale.

The visual inspection process (SOP# VV-QUAL-06066) is deficient, not requiring investigations for 100% visual inspection failures, even for critical defects. Particulate identification is not required until AQL inspection. Examples include Dexamethasone, Moxifloxacin, and Ketorolac products released after initial 100% visual inspection failures. A Process Verification study for DMK, DM, and Moxifloxacin also showed critical defect failures (fibers, particles) in 100% visual inspection without deviation or investigation.

Confirmatory testing for particles was not conducted for Triamcinolone-Moxifloxacin ICI retain samples linked to increased inflammation complaints, and visual inspectors are not trained on API residue identification. A deviation investigation (QE-0000142) for glass particles found during AQL inspection of DM Lot failed to include an impact and risk analysis for the glass.

Over 1000 complaints for Klarity-Cyclosporine 0.1% (clogged/leaking/empty/underfilled bottles, mold) between 12/2021 and 03