In short: On March 10, 2023, FDA issued a Form 483 with 4 observations to Hugel, Inc. (Site 2) in Chuncheon-si, South Korea (FEI 3012163998) after an inspection that ran Feb 27 – Mar 10, 2023. The investigators were Yetao Jin and Zhong Li.
What FDA observed
Preview: the opening words of each observation- 01
Your finn lacks an established cleaning and disinfection program to prevent the introduction of microbial contaminationIDi…
- 02
Laboratory records are deficient in that your firm has not established adequate procedural controls to ensure…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Your environmental monitoring program for the Buildint} drug substance…
This inspection in context
Yetao Jin
4 documents · 2019–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Iceland.
The firmHugel, Inc. (Site 2) history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sMore form 483s
Browse other documents of this type.
Questions about this 483
What did FDA find at Hugel, Inc. (Site 2)?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Hugel, Inc. (Site 2)?
Yetao Jin and Zhong Li are named on this Form 483, for the inspection of Feb 27 – Mar 10, 2023. Each investigator has a profile showing what they cite most.
When was Hugel, Inc. (Site 2) inspected by FDA?
The inspection ran Feb 27 – Mar 10, 2023, and the Form 483 is dated March 10, 2023.
How do I get the full Form 483 for Hugel, Inc. (Site 2)?
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.