Banyan USA LLC
FDA inspection history in Hauppauge, New York, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Hauppauge, New York.
Cited most
Across all Banyan USA observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.40Document controls1
The complete Banyan USA file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Hauppauge, New York
One Form 483 · 2023 · 9 observations
Latest: Form 483, Sep 12, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-12 | 483 Form 483 | Hauppauge, New York | 9 | $99 |
Investigators on these documents
FEI number 3020737798 · most recent document Sep 12, 2023
About Banyan USA LLC
How many FDA Form 483s has Banyan USA LLC received?
FDA Intel has 1 Form 483 on file for Banyan USA LLC; the most recent is dated Sep 12, 2023.
When was Banyan USA LLC last inspected by FDA?
The most recent FDA inspection document on file for Banyan USA LLC is a Form 483 dated Sep 12, 2023, for the site in Hauppauge, New York.
What did FDA cite at Banyan USA LLC?
The regulations cited most in the observations on file for Banyan USA LLC are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.20(c) (Management responsibility), 1 time.