# FDA 483 - New Era Pharmacy, LLC - October 04, 2016

Source: https://www.keypedia.com/records/483/new-era-pharmacy-llc/aaa994eb-9dab-4c5b-9ae8-906d9d5413c3

> FDA 483 for New Era Pharmacy, LLC on October 04, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New Era Pharmacy, LLC
- Inspection Date: 2016-10-04
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: The FDA Form 483 details multiple deficiencies in aseptic processing, environmental monitoring, personnel practices, sterilization, and cleaning procedures at a facility producing sterile drug products.

**Environmental Monitoring & Aseptic Processing:**
*   Smoke study qualification of sterile production suites lacked video and condition descriptions, preventing confirmation.
*   Initial sterile compounding suite qualification did not include dynamic conditions.
*   Environmental monitoring (air, surface) and personnel monitoring (microbial) are not performed during sterile production.
*   SOP No. 9 "Environmental Monitoring/Testing" specifies air sampling "(b)(4)", surface testing "every (b)(4)", and testing "every (b)(4)" to verify USP <797> ISO 8, ISO 7, and ISO 5 air quality, but these are not followed during production.

**Personnel Practices:**
*   SOP No. 12 "Glove fingertip sampling and gowning documentation" is deficient as it doesn't require operators to roll fingertips side-to-side.
*   SOP No. 13 "Garbing, Gowning and Gloving Process..." doesn't require sampling of gown areas (forehead, face, shoulder, chest).
*   SOP No. 10 "Garbing Procedure Technique" is deficient; it doesn't state face/neck should be completely covered or address street clothing exposure in the ISO7 room.
*

## Related Documents

- [WARNING_LETTER - 2016-10-04](https://www.keypedia.com/records/warning_letter/new-era-pharmacy-llc/3a5ca8c9-e5c0-4363-8c8b-bb2b706abce4)
- [483 - 2019-11-27](https://www.keypedia.com/records/483/new-era-pharmacy-llc/dff808b7-a5c3-4f2d-bced-9b1a09f51dd5)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)
- [Entrepreneur](https://www.keypedia.com/people/jeffery-a-johnson/bd970f21-7ff0-489d-ae46-ea3240a2ca8f)

Company: https://www.keypedia.com/companies/new-era-pharmacy-llc/a3538a4a-a851-418f-b791-cb14d97df36a

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