# FDA 483 - Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy - August 01, 2017

Source: https://www.keypedia.com/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/1e562a60-5230-46ef-b18c-049c325d1603

> FDA 483 for Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy on August 01, 2017. 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: 2017-08-01
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: This FDA Form 483 details observations from an inspection concerning the production of Tri-Mix (Prost/Pap/Phent 10 mcg/30 mg/1 mg/mL) injectable.

Key violations include:
1.  **Inadequate Disinfection:** On 7/17/2017, non-sterile materials for Tri-Mix production (Lot (b)(6)) were placed directly into an ISO-5 biological safety cabinet (BSC) without proper disinfection of the outer surface.
2.  **Dirty/Damaged Equipment & Facilities:**
    *   Residue was observed on HEPA filter screens in ISO 7 Prep Area and Anteroom.
    *   Residue was found on the exterior of a balance in the ISO 7 Prep Area.
    *   Three cracks (2.5, 8, and 3.5 inches) were noted on a glass window between the ISO 7 Anteroom and ISO 7 Positive Pressure Room.
3.  **Expired ISO-5 Certifications:** From 6/2/2017 to 7/19/2017, 72 sterile drug products were made while certifications for two ISO-5 units (BSC in Negative Pressure Room and unit in Positive Pressure Room) expired in June 2017.
4.  **Lack of Dynamic Airflow Analysis:** In situ air pattern

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

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913