# FDA 483 - First Pharma Associates LLC dba Riverpoint Pharmacy - December 16, 2016

Source: https://www.keypedia.com/records/483/first-pharma-associates-llc-dba-riverpoint-pharmacy/724b1def-737b-4b37-98f2-7a3cb1389811

> FDA 483 for First Pharma Associates LLC dba Riverpoint Pharmacy on December 16, 2016. 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: 2016-12-16
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: On December 16, 2016, the FDA issued a Form 483 to First Pharma Associates, LLC dba Riverpoint Pharmacy, a producer of sterile drug products located at 528 E Spokane Falls Blvd, Suite 110, Spokane, WA 99202. The inspection, conducted from December 6-9 and 12-16, 2016, revealed four observations regarding facility conditions and quality systems.

Observation 1 noted that ISO-classified areas had difficult-to-clean, particle-generating, or visibly dirty equipment and surfaces. Specific issues included chipped drywall in the ISO 7 Buffer Room, apparent wood frames around HEPA filters, peeling laminate on a pass-through box, dust buildup on a light in the Prep Room, difficult-to-clean vinyl stools, black residue on a biological safety cabinet (BSC), orange buildup in the Buffer Room, buildup on a computer keyboard in the Powder Hood, and black staining on Buffer Room and Anteroom floors.

Observation 2 identified the presence of sinks or drains in the cleanroom where the ISO 5 area is located, specifically a hand wash sink in the Prep Room near a Powder Hood and BSC.

Observation 3 stated that the ISO 5 area was located within a non-classified room. The Prep Room, containing the ISO 5 BSC, was not supplied by HEPA-filtered air and was exposed to the

## Related Documents

- [483_RESPONSE - 2016-12-16](https://www.keypedia.com/records/483_response/first-pharma-associates-llc-dba-riverpoint-pharmacy/4e4efd0f-d55f-4ff8-9557-2e026f34bc4f)
- [WARNING_LETTER - 2016-12-16](https://www.keypedia.com/records/warning_letter/first-pharma-associates-llc-dba-riverpoint-pharmacy/ecd80081-5392-46aa-922e-2916b1a55f92)
- [483 - 2019-06-07](https://www.keypedia.com/records/483/first-pharma-associates-llc-dba-riverpoint-pharmacy/35993aa8-0d1e-44e6-a6f9-882195298dff)
- [483 - 2019-06-07](https://www.keypedia.com/records/483/first-pharma-associates-llc-dba-riverpoint-pharmacy/97e91d22-4912-449d-a6bd-6e0e91405e21)
- [483 - 2021-03-03](https://www.keypedia.com/records/483/first-pharma-associates-llc-dba-riverpoint-pharmacy/fad2d56c-ac84-4d19-9a43-de4bcf41488d)

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

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