FDA 483 - OSRX Inc. - April 25, 2019

During an inspection from August 28, 2018, to April 25, 2019, the FDA observed deficiencies at Pinnacle Compounding, a compounding pharmacy located at 1120 Kensington Ave Unit E, Missoula, MT. The inspection was issued to Amy A. Frost, Pharmacist-in-Charge.

The primary observation noted was that the sterilization process intended to render final products sterile was inadequate. Specifically, the firm failed to conduct [redacted] testing on [redacted] used to sterilize Atropine Sulfate 0.01% Sterile Ophthalmic Solution, lot 021219OS1010, manufactured on February 12, 2019, with a 180-day beyond-use date (BUD).

Furthermore, Pinnacle Compounding released products purported to be sterile despite the [redacted] used in their production failing to meet the manufacturer's [redacted] test specifications. Examples include: * Prednisolone/Ketorolac 1%/0.5% Ophthalmic Solution, lot 021319OS1001, manufactured on February 13, 2019 (180-day BUD), was released with a [redacted] testing result of [redacted], which is below the manufacturer's specification of [redacted]. * Tim