# FDA 483 - OSRX Inc. - April 25, 2019

Source: https://www.keypedia.com/records/483/osrx-inc/23b35fd9-37bc-4337-a5ff-a8a3bc4ab546

> FDA 483 for OSRX Inc. on April 25, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OSRX Inc.
- Inspection Date: 2019-04-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

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## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [Compliance Officer](https://www.keypedia.com/people/andrew-k-haack/d0e236ac-3223-43e0-8378-300de21b19f5)

Company: https://www.keypedia.com/companies/osrx-inc/aead9fd9-6208-40fd-bc2a-d477072c53ae

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c