HansBiomed USA, Inc
FDA inspection history in Englewood Cliffs, New Jersey, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Englewood Cliffs, New Jersey.
Cited most
Across all HansBiomed USA observations on file
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.22Quality audit1
The complete HansBiomed USA file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Englewood Cliffs, New Jersey
One Form 483 · 2022 · 4 observations
Latest: Form 483, Nov 8, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-08 | 483 Form 483 | Englewood Cliffs, New Jersey | 4 | $99 |
Investigators on these documents
FEI number 3008778066 · most recent document Nov 8, 2022
About HansBiomed USA, Inc
How many FDA Form 483s has HansBiomed USA, Inc received?
FDA Intel has 1 Form 483 on file for HansBiomed USA, Inc; the most recent is dated Nov 8, 2022.
When was HansBiomed USA, Inc last inspected by FDA?
The most recent FDA inspection document on file for HansBiomed USA, Inc is a Form 483 dated Nov 8, 2022, for the site in Englewood Cliffs, New Jersey.
What did FDA cite at HansBiomed USA, Inc?
The regulations cited most in the observations on file for HansBiomed USA, Inc are 21 CFR 820.198(a) (Complaint files), 2 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.22 (Quality audit), 1 time.