# FDA 483 - Episciences Inc - March 11, 2022

Source: https://www.keypedia.com/records/483/episciences-inc/f0a2ed64-65f2-4b50-909a-b512ce102c26

> FDA 483 for Episciences Inc on March 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Episciences Inc
- Inspection Date: 2022-03-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Episciences Inc. in Boise, ID, a drug manufacturer of non-sterile topical products, revealed significant deficiencies in their quality control and manufacturing processes. Observations included inadequate finished product testing for identity, strength, and microbial contamination, as well as insufficient investigations into out-of-specification results. The firm also failed to adequately validate manufacturing processes, ensure proper sampling, verify raw material identity, and maintain adequate equipment cleaning procedures.

## Related Documents

- [WARNING_LETTER - 2015-12-31](https://www.keypedia.com/records/warning_letter/episciences-inc/c5aa01d1-5f58-4194-a930-d049b8b14593)
- [WARNING_LETTER - 2022-03-11](https://www.keypedia.com/records/warning_letter/episciences-inc/124a1c66-a49e-4963-a85a-e9fa50544eac)
- [483 - 2024-01-29](https://www.keypedia.com/records/483/episciences-inc/45f24b5a-3fb6-4cbd-8425-19198c0410de)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.keypedia.com/companies/episciences-inc/db9de422-87ad-44ad-bf37-a1cd35fdb978

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822