Hugel, Inc. (Site 2)
Form 483 issued August 20, 2021 · Chuncheon-si, South Korea
- Inspection
- Aug 12 – Aug 20, 2021
- Observations
- 6
- Pages
- 3
- FEI number
- 3012163998
In short: On August 20, 2021, FDA issued a Form 483 with 6 observations to Hugel, Inc. (Site 2) in Chuncheon-si, Gangwon-do (FEI 3012163998) after an inspection that ran Aug 12 – Aug 20, 2021.
What FDA observed
Preview: the opening words of each observation- 01
Clostridium botulinum spore containment in the drug substance manufacturing areas is i uate to mitigate spore…
- 02
Decontamination of Clostridium botulinum spores and toxin in the drug substance manufacturing…
- 03
Environmental monitoring is insufficient to ensure that the drug product manufacturing areas are not contaminated with…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Hugel, Inc. (Site 2)?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
When was Hugel, Inc. (Site 2) inspected by FDA?
The inspection ran Aug 12 – Aug 20, 2021, and the Form 483 is dated August 20, 2021.
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.