# FDA 483 - First Pharma Associates LLC dba Riverpoint Pharmacy - June 07, 2019

Source: https://www.globalkeysolutions.net/records/483/first-pharma-associates-llc-dba-riverpoint-pharmacy/97e91d22-4912-449d-a6bd-6e0e91405e21

> FDA 483 for First Pharma Associates LLC dba Riverpoint Pharmacy on June 07, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: First Pharma Associates LLC dba Riverpoint Pharmacy
- Inspection Date: 2019-06-07
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: The FDA Form 483 documents multiple violations at a facility producing sterile and non-sterile drug products.

**Facility and Operations:** The facility includes an ISO-7 Buffer room with an ISO-5 Biological Safety Cabinet (BSC) for sterile drug production, an ISO-7 Ante room for weighing and compounding, an ISO-8 Gowning room, and a non-sterile processing laboratory.

**Violations and Observations:**

*   **Non-microbial Contamination:** An unidentified object was found on the floor of the ISO-7 Buffer room on June 3, 2019.
*   **Aseptic Technique Breaches:**
    *   Personnel manually contacted the inner surface of vials during stoppering of Prostaglandin 20mcg/ml Procaine 0.1% Injection on June 5, 2019, inside the ISO-5 BSC.
    *   Technician's hand blocked first-pass air during aseptic compounding of Serum Tears 20% Eye Drops PF solution on June 3, 2019. A tray of caps and tips was also placed in front of return air vents in the ISO-5 BSC.
*   **Cross-Contamination (Hazardous Drugs):**
    *   Inadequate deactivation of hazardous products in the (b)(4) hood (Model (b)(4), SN (b)(4)) in the ISO-7

## Related Documents

- [483 - 2016-12-16](https://www.globalkeysolutions.net/records/483/first-pharma-associates-llc-dba-riverpoint-pharmacy/724b1def-737b-4b37-98f2-7a3cb1389811)
- [483_RESPONSE - 2016-12-16](https://www.globalkeysolutions.net/records/483_response/first-pharma-associates-llc-dba-riverpoint-pharmacy/4e4efd0f-d55f-4ff8-9557-2e026f34bc4f)
- [WARNING_LETTER - 2016-12-16](https://www.globalkeysolutions.net/records/warning_letter/first-pharma-associates-llc-dba-riverpoint-pharmacy/ecd80081-5392-46aa-922e-2916b1a55f92)
- [483 - 2019-06-07](https://www.globalkeysolutions.net/records/483/first-pharma-associates-llc-dba-riverpoint-pharmacy/35993aa8-0d1e-44e6-a6f9-882195298dff)
- [483 - 2021-03-03](https://www.globalkeysolutions.net/records/483/first-pharma-associates-llc-dba-riverpoint-pharmacy/fad2d56c-ac84-4d19-9a43-de4bcf41488d)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [SVP Consulting & Operations](https://www.globalkeysolutions.net/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

Company: https://www.globalkeysolutions.net/companies/first-pharma-associates-llc-dba-riverpoint-pharmacy/2c4eda16-7aa2-49cb-b9bc-29d3a819a37f

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