FDA WARNING_LETTER - OSRX, Inc. - October 25, 2024

On April 23, 2025, the FDA issued Warning Letter #701889 to OSRX, Inc., an outsourcing facility in Missoula, Montana, following an inspection from October 16-25, 2024. The inspection revealed that OSRX's drug products failed to meet Section 503B of the FDCA conditions, jeopardizing exemptions from drug approval, adequate directions for use, and Drug Supply Chain Security Act requirements.

Key violations include misbranding due to inadequate labeling (missing active/inactive ingredients, adverse event reporting info, and directions for use) on products like Prednisolone Phosphate 1% Moxifloxacin 0.5% 5ml Sterile Ophthalmic Solution. The facility also produced adulterated drug products under insanitary conditions, specifically failing to perform adequate dynamic smoke studies in ISO 5 critical areas, not thoroughly investigating microbial contamination in aseptic processing areas, and lacking adequate CGMP controls.

Specific CGMP violations cited include failure to establish procedures for preventing microbiological contamination (21 CFR 211.113(b)), investigate discrepancies (21 CFR 211.192), monitor environmental conditions (21 CFR 211.42(c)(10)(iv)), and control manufacturing processes (21 CFR 211.110(a)).

The FDA found OSRX's November