POET BIOREFINING - LEIPSIC, LLC
Form 483 issued January 17, 2024 · Leipsic, Ohio
- Inspection
- Jan 10 – Jan 17, 2024
- Investigator
- Lisa R. Hilliard
- Observations
- 5
- Pages
- 5
- FEI number
- 3006510731
In short: On January 17, 2024, FDA issued a Form 483 with 5 observations to POET BIOREFINING - LEIPSIC, LLC in Leipsic, Ohio (FEI 3006510731) after an inspection that ran Jan 10 – Jan 17, 2024. The investigator was Lisa R. Hilliard. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 4 of 5 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your quality unit does not exercise its responsibility to ensure the Undenatured and Denatured 190 Proof…
- 02
Procedures and processes necessary to ensure the finished API manufactured at your facility meet specifications for…
- 03
A Process Validation program has not been established to demonstrate that your manufacturing process can reproducibly…
- 04
An on-going stability testing program was not designed to monitor the stability characteristics and to confirm…
This inspection in context
Lisa R. Hilliard
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmPOET BIOREFINING - LEIPSIC, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at POET BIOREFINING - LEIPSIC, LLC?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected POET BIOREFINING - LEIPSIC, LLC?
Lisa R. Hilliard is named on this Form 483, for the inspection of Jan 10 – Jan 17, 2024. Each investigator has a profile showing what they cite most.
When was POET BIOREFINING - LEIPSIC, LLC inspected by FDA?
The inspection ran Jan 10 – Jan 17, 2024, and the Form 483 is dated January 17, 2024.
How do I get the full Form 483 for POET BIOREFINING - LEIPSIC, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.