Lifecore Biomedical, LLC
Form 483 issued February 22, 2017 · Chaska, Minnesota
- Inspection
- Feb 14 – Feb 22, 2017
- Investigators
- Joseph D. Gong· Susan M. Matthias
- Observations
- 2
- Pages
- 3
- FEI number
- 1000115753
In short: On February 22, 2017, FDA issued a Form 483 with 2 observations to Lifecore Biomedical, LLC in Chaska, Minnesota (FEI 1000115753) after an inspection that ran Feb 14 – Feb 22, 2017. The investigators were Joseph D. Gong and Susan M. Matthias. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.75 (1×) · 820.100 (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
Procedures for corrective and preventive action have…
This inspection in context
Joseph D. Gong
4 documents · 2017–2021
Cites 820.100 (corrective and preventive action) 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 and cAPA. 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?
Joseph D. Gong and Susan M. Matthias are named on this Form 483, for the inspection of Feb 14 – Feb 22, 2017. Each investigator has a profile showing what they cite most.
When was Lifecore Biomedical, LLC inspected by FDA?
The inspection ran Feb 14 – Feb 22, 2017, and the Form 483 is dated February 22, 2017.
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.