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

Source: https://www.keypedia.com/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/468bc024-1c52-4160-9e7b-240940d98329

> 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: Los Angeles District Office
- Summary: This FDA Form 483 documents observations from an inspection related to the sterile production of Epinephrine/Ketorolac/Ropivicaine 0.0006%/0.03%/0.2% and non-sterile production of cytotoxic drugs.

Key violations include:
1.  **Inadequate Disinfection of Materials:** On September 9, 2020, rubber stoppers of vials (Epinephrine, Ketorolac, Ropivicaine, Sodium Chloride) were swabbed with non-sterile wipes prior to use in an ISO 5 Biosafety Cabinet for sterile drug production (Lots 6373, 6368, 6366). The material was then transferred to syringes without further sterilization.
2.  **Poor Air Quality/Facility Design:** A July 10, 2019, smoke study showed stagnant smoke in the ISO 7 Hazard Room ceiling, near the ISO 5 Biosafety Cabinet. A June 12, 2018, study indicated smoke flowing from the ISO 7 Hazard Room into the ISO 5 Biosafety Cabinet, demonstrating poor air flow and potential contamination risk.
3.  **Dirty Equipment/Surfaces in Aseptic Areas:** On September 11, 2020, the ISO 5 Biosafety Cabinet and surrounding ISO 7 Hazard Room exhibited visibly dirty surfaces, including white residue

## 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 - 2017-08-01](https://www.keypedia.com/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/52684c9b-b6dd-4ee6-84f8-9fcecb49e25a)
- [483 - 2020-09-23](https://www.keypedia.com/records/483/kelley-ross-associates-inc-dba-kelley-ross-compounding-pharmacy/9baaf485-bf9d-48a4-a901-a97da5908536)

## Related Officers

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

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/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b