Hugel, Inc.
Form 483 issued August 20, 2021 · Chuncheon, South Korea
- Inspection
- Aug 12 – Aug 20, 2021
- Investigators
- Madushini Dharmasena· Mekonnen Lemma Dechassa
- Observations
- 7
- Pages
- 3
In short: On August 20, 2021, FDA issued a Form 483 with 7 observations to Hugel, Inc. in Chuncheon, Gangwon after an inspection that ran Aug 12 – Aug 20, 2021. The investigators were Madushini Dharmasena and Mekonnen Lemma Dechassa. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 3 systems, led by facilities & equipment.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Clostridium botulinum spore containment in the drug substance manufacturing areas is inadequate to mitigate spore cross…
- 02
Decontamination of Clostridium botulinum spores and toxin in the drug substance…
- 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
Madushini Dharmasena
13 documents · 2019–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmHugel, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hugel, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Hugel, Inc.?
Madushini Dharmasena and Mekonnen Lemma Dechassa are named on this Form 483, for the inspection of Aug 12 – Aug 20, 2021. Each investigator has a profile showing what they cite most.
When was Hugel, Inc. 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.?
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.