# FDA 483 - POET Biorefining - Leipsic, LLC - January 17, 2024

Source: https://www.globalkeysolutions.net/records/483/poet-biorefining-leipsic-llc/5ff69206-7241-4dca-b12e-6ae27fe64a7b

> FDA 483 for POET Biorefining - Leipsic, LLC on January 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: POET Biorefining - Leipsic, LLC
- Inspection Date: 2024-01-17
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of POET Biorefining - Leipsic, LLC revealed significant deficiencies in the firm's quality unit oversight and manufacturing controls for Purified Alcohol (PA) or API Ethanol. The company failed to establish adequate written procedures for quality control, process validation, stability testing, and microbiological specifications. These observations indicate a lack of robust systems to ensure the quality and purity of their active pharmaceutical ingredients.

## Related Officers

- [Consumer Safety Officer , Investigator](https://www.globalkeysolutions.net/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

Company: https://www.globalkeysolutions.net/companies/poet-biorefining-leipsic-llc/0c759a20-a1b7-4380-ada7-2a537808e9d3

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22