# FDA 483 - Columbia River Pharmacy LLC (DBA Malley's Compounding Pharmacy) - August 16, 2019

Source: https://www.globalkeysolutions.net/records/483/columbia-river-pharmacy-llc-dba-malleys-compounding-pharmacy/a943409b-f04d-4bee-aaab-76621ab07737

> FDA 483 for Columbia River Pharmacy LLC (DBA Malley's Compounding Pharmacy) on August 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Columbia River Pharmacy LLC (DBA Malley's Compounding Pharmacy)
- Inspection Date: 2019-08-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Columbia River Pharmacy LLC (DBA Malley's Compounding Pharmacy) in Richland, WA, was inspected regarding its production of nonsterile drug products. The inspection revealed significant deficiencies in preventing cross-contamination of hazardous drugs and maintaining adequate air quality in the compounding lab. These issues indicate a lack of proper controls for facility design and cleaning procedures.

## Related Documents

- [483_RESPONSE - 2019-08-16](https://www.globalkeysolutions.net/records/483_response/columbia-river-pharmacy-llc-dba-malleys-compounding-pharmacy/7c03fc2d-c01c-4883-911f-6e97a458281c)
- [483 - 2019-08-16](https://www.globalkeysolutions.net/records/483/columbia-river-pharmacy-llc-dba-malleys-compounding-pharmacy/e5ef8c8f-4efd-4eeb-80a0-6bc61f18910c)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/joshua-p-wireman/1f5cca58-4a35-4b1a-b344-35820b1e58fb)

Company: https://www.globalkeysolutions.net/companies/columbia-river-pharmacy-llc-dba-malleys-compounding-pharmacy/f714f11a-4931-41de-abf5-e6064ee05f04

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822