Lifecore Biomedical, LLC
Form 483 issued March 12, 2025 · Chaska, Minnesota
- Inspection
- Mar 3 – Mar 12, 2025
- Investigators
- Roger F. Zabinski· Tyler Peterson
- Observations
- 2
- Pages
- 4
- FEI number
- 1000115753
In short: On March 12, 2025, FDA issued a Form 483 with 2 observations to Lifecore Biomedical, LLC in Chaska, Minnesota (FEI 1000115753) after an inspection that ran Mar 3 – Mar 12, 2025. The investigators were Roger F. Zabinski and Tyler Peterson. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.67(a) (1×) · 211.166(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
The written stability testing…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmLifecore Biomedical, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lifecore Biomedical, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Lifecore Biomedical, LLC?
Roger F. Zabinski and Tyler Peterson are named on this Form 483, for the inspection of Mar 3 – Mar 12, 2025. Each investigator has a profile showing what they cite most.
When was Lifecore Biomedical, LLC inspected by FDA?
The inspection ran Mar 3 – Mar 12, 2025, and the Form 483 is dated March 12, 2025.
How do I get the full Form 483 for Lifecore Biomedical, 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.