HansBiomed USA, Inc
Form 483 issued November 8, 2022 · Englewood Cliffs, New Jersey
- Inspection
- Nov 7 – Nov 8, 2022
- Investigator
- Kwong P. Lee
- Observations
- 4
- Pages
- 4
- FEI number
- 3008778066
In short: On November 8, 2022, FDA issued a Form 483 with 4 observations to HansBiomed USA, Inc in Englewood Cliffs, New Jersey (FEI 3008778066) after an inspection that ran Nov 7 – Nov 8, 2022. The investigator was Kwong P. Lee. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
3 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Quality audits were not performed at defined intervals to determine whether the quality system activities and…
- 04
Records of complaint investigations do…
This inspection in context
Kwong P. Lee
12 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmHansBiomed USA, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at HansBiomed USA, Inc?
FDA listed 4 observations on this Form 483, mostly about cAPA and management controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected HansBiomed USA, Inc?
Kwong P. Lee is named on this Form 483, for the inspection of Nov 7 – Nov 8, 2022. Each investigator has a profile showing what they cite most.
When was HansBiomed USA, Inc inspected by FDA?
The inspection ran Nov 7 – Nov 8, 2022, and the Form 483 is dated November 8, 2022.
How do I get the full Form 483 for HansBiomed USA, 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.