# FDA 483 - Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy - September 23, 2020

Source: https://www.globalkeysolutions.net/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/9baaf485-bf9d-48a4-a901-a97da5908536

> FDA 483 for Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy on September 23, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy
- Inspection Date: 2020-09-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy in Seattle, WA, revealed significant deficiencies in both sterile and non-sterile drug production. Observations included inadequate disinfection of materials, poor facility design allowing air quality issues, visibly dirty aseptic processing areas, improper personnel gowning, and insufficient cleaning procedures for equipment used with hazardous drugs, raising concerns about product sterility and cross-contamination.

## Related Documents

- [483 - 2017-08-01](https://www.globalkeysolutions.net/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/1e562a60-5230-46ef-b18c-049c325d1603)
- [483 - 2017-08-01](https://www.globalkeysolutions.net/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/52684c9b-b6dd-4ee6-84f8-9fcecb49e25a)
- [483 - 2020-09-23](https://www.globalkeysolutions.net/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/468bc024-1c52-4160-9e7b-240940d98329)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.globalkeysolutions.net/companies/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/cfa988e6-9023-48eb-909d-7d413c387a77

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6