Lifecore Biomedical, LLC
Form 483 issued January 21, 2021 · Chaska, Minnesota
- Inspection
- Jan 11 – Jan 21, 2021
- Investigator
- Christina L. Bigham
- Observations
- 2
- Pages
- 4
- FEI number
- 1000115753
In short: On January 21, 2021, FDA issued a Form 483 with 2 observations to Lifecore Biomedical, LLC in Chaska, Minnesota (FEI 1000115753) after an inspection that ran Jan 11 – Jan 21, 2021. The investigator was Christina L. Bigham. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75 (1×) · 820.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
There is no agreement with suppliers, contractors and consultants to notify you of changes in…
This inspection in context
Christina L. Bigham
11 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Minnesota.
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 820.75
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 production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Lifecore Biomedical, LLC?
Christina L. Bigham is named on this Form 483, for the inspection of Jan 11 – Jan 21, 2021. Each investigator has a profile showing what they cite most.
When was Lifecore Biomedical, LLC inspected by FDA?
The inspection ran Jan 11 – Jan 21, 2021, and the Form 483 is dated January 21, 2021.
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.