Lifecore Biomedical, LLC
FDA inspection history in Chaska, Minnesota, 2004 to 2025
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2004: one warning letter; 2017: one Form 483; 2019: one Form 483; 2021: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One warning letter, at Chaska, Minnesota.
- 2017–21Three Form 483s, at Chaska, Minnesota.
- 2019The longest 483 on file: 9 observations over 9 pages at Chaska, Minnesota.
- 2025One Form 483, at Chaska, Minnesota.
Cited most
Across all Lifecore Biomedical observations on file
- 21 CFR 820.75Process validation2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.166(a)Stability testing1
The complete Lifecore Biomedical file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Chaska, Minnesota
Four Form 483s and one warning letter · 2004 to 2025 · 15 observations
Latest: Form 483, Mar 12, 2025 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-12 | 483 Form 483 | Chaska, Minnesota | 2 | $99 |
| 2021-01-21 | 483 Form 483 | Chaska, Minnesota | 2 | $99 |
| 2019-02-26 | 483 Form 483 | Chaska, Minnesota | 9 | $99 |
| 2017-02-22 | 483 Form 483 | Chaska, Minnesota | 2 | $99 |
| 2004-10-08 | Warning letter Warning letter | Chaska, Minnesota | — | $99 |
Investigators on these documents
Christina L. Bigham (1)Joseph D. Gong (1)Roger F. Zabinski (1)Ross J. Grigsby (1)Scott A. Golladay (1)Susan M. Matthias (1)Tyler Peterson (1)
FEI number 1000115753 · most recent document Mar 12, 2025
About Lifecore Biomedical, LLC
How many FDA Form 483s has Lifecore Biomedical, LLC received?
FDA Intel has 4 Form 483s on file for Lifecore Biomedical, LLC; the most recent is dated Mar 12, 2025.
When was Lifecore Biomedical, LLC last inspected by FDA?
The most recent FDA inspection document on file for Lifecore Biomedical, LLC is a Form 483 dated Mar 12, 2025, for the site in Chaska, Minnesota.
What did FDA cite at Lifecore Biomedical, LLC?
The regulations cited most in the observations on file for Lifecore Biomedical, LLC are 21 CFR 820.75 (Process validation), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.
Has Lifecore Biomedical, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Lifecore Biomedical, LLC; the most recent is dated Oct 8, 2004.