Lifecore Biomedical, LLC
Form 483 issued February 26, 2019 · Chaska, Minnesota
- Inspection
- Jan 28 – Feb 26, 2019
- Investigators
- Ross J. Grigsby· Scott A. Golladay
- Observations
- 9
- Pages
- 9
- FEI number
- 1000115753
In short: On February 26, 2019, FDA issued a Form 483 with 9 observations to Lifecore Biomedical, LLC in Chaska, Minnesota (FEI 1000115753) after an inspection that ran Jan 28 – Feb 26, 2019. The investigators were Ross J. Grigsby and Scott A. Golladay. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Employees are not given training in the particular operations they perform as part of their function…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Establishment of the reliability of the closure supplier's report of analyses is deficient in that the…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Ross J. Grigsby
8 documents · 2017–2021
Cites 211.22 (responsibilities of quality control unit) 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 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lifecore Biomedical, LLC?
FDA listed 9 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Lifecore Biomedical, LLC?
Ross J. Grigsby and Scott A. Golladay are named on this Form 483, for the inspection of Jan 28 – Feb 26, 2019. Each investigator has a profile showing what they cite most.
When was Lifecore Biomedical, LLC inspected by FDA?
The inspection ran Jan 28 – Feb 26, 2019, and the Form 483 is dated February 26, 2019.
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.