# FDA 483 - Emery Pharma - April 09, 2021

Source: https://www.keypedia.com/records/483/emery-pharma/24d0701e-3f10-4dd3-a311-e1c2e12773bc

> FDA 483 for Emery Pharma on April 09, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emery Pharma
- Inspection Date: 2021-04-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Najafi Pharma, Inc. (d.b.a. Emery Pharma) in Alameda, CA, a control testing laboratory, was inspected from April 7-9, 2021. The inspection revealed significant data integrity issues, including a failure to follow SOPs regarding unique user credentials and the security of raw data and audit trail files. These conditions indicate a moderate severity of non-compliance related to data control and record keeping.

## Related Documents

- [EIR - 2021-04-09](https://www.keypedia.com/records/eir/emery-pharma/eded639d-818b-4f87-8cda-6810bb76e525)
- [483 - 2025-07-09](https://www.keypedia.com/records/483/emery-pharma/962bab72-9941-466d-ba7b-8d2061ed982c)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Lisa Tran, CSO](https://www.keypedia.com/people/lisa-tran-cso/774b83a8-4880-4cdd-9b9f-a0f77ef03509)
- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.keypedia.com/companies/emery-pharma/cb6bbdca-e6b7-4692-8f63-af125a6dffdd

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b