La Crosse Milling Company
Form 483 issued November 22, 2024 · Cochrane, Wisconsin
- Observations
- 5
- Pages
- 5
- FEI number
- 2125677
In short: On November 22, 2024, FDA issued a Form 483 with 5 observations to La Crosse Milling Company in Cochrane, Wisconsin (FEI 2125677). Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.125 (labeling issuance).
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities of the Quality Unit are not in…
- 02
Your retrospective process validation does not identify or monitor critical process parameters or critical quality attributes…
- 03
Your cleaning validation lacks a protocol describing equipment to be cleaned, procedures, materials, acceptable cleaning levels…
- 04
Procedures for label control and reconciliation are not established, in…
This inspection in context
Questions about this 483
What did FDA find at La Crosse Milling Company?
FDA listed 5 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.125 (labeling issuance). The opening words of each observation are shown on this page.
When was La Crosse Milling Company inspected by FDA?
This Form 483 is dated November 22, 2024.
How do I get the full Form 483 for La Crosse Milling Company?
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.