Hugel, Inc. (Site 2)
Form 483 issued February 1, 2024 · Chuncheon-si, South Korea
- Observations
- 2
- Pages
- 1
- FEI number
- 3012163998
In short: On February 1, 2024, FDA issued a Form 483 with 2 observations to Hugel, Inc. (Site 2) in Chuncheon-si, Gangwon-do (FEI 3012163998). Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Visual inspection procedures are…
This inspection in context
Questions about this 483
What did FDA find at Hugel, Inc. (Site 2)?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Hugel, Inc. (Site 2) inspected by FDA?
This Form 483 is dated February 1, 2024.
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.