# 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/52684c9b-b6dd-4ee6-84f8-9fcecb49e25a

> 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: The FDA Form 483 inspection revealed multiple deficiencies in aseptic processing and quality control at the facility.

**Facility and Operations:** The facility produces Tri-Mix (Prost/Pap/Phent 10 mcg/30 mg/1 mg/mL) injectable, with production observed on 7/17/2017 for Lot number (b) (6). Operations involve ISO-5 biological safety cabinets (BSC) and ISO 7 Prep/Anteroom areas.

**Violations and Observations:**
*   **Disinfection:** Non-sterile materials (plastic bag with in-process materials, containers, closures) were placed directly into an ISO-5 BSC (Serial (b) (4)) without adequate disinfection.
*   **Cleanliness:** Apparent residue was observed on HEPA filter screens in ISO 7 areas and on the exterior of a (b) (4) balance in the ISO 7 Prep Area. Three cracks (2.5, 8, 3.5 inches) were found on a glass window between the ISO 7 Anteroom and Positive Pressure Room.
*   **ISO Certification:** ISO-5 BSCs (Serial (b) (4) in Negative Pressure Room and Serial (b) (4) in Positive Pressure Room) had expired certifications (June 2017), yet 72 sterile drug products were made between 6/2/2017 and

## Related Documents

- [483 - 2017-08-01](https://www.keypedia.com/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/1e562a60-5230-46ef-b18c-049c325d1603)
- [483 - 2020-09-23](https://www.keypedia.com/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/9baaf485-bf9d-48a4-a901-a97da5908536)
- [483 - 2020-09-23](https://www.keypedia.com/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/468bc024-1c52-4160-9e7b-240940d98329)

## Related Officers

- [Registered Nurse](https://www.keypedia.com/people/gerard-de-leon/1c84d3b7-b56f-4c97-aa3f-a96862c348cd)
- [Consumer Safety Officer](https://www.keypedia.com/people/kenneth-o-gee/d61312c0-1422-4487-a5d6-ec6e76d242ee)

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