Nikao, Inc
FDA inspection history in Weston, Florida, 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 Weston, Florida.
Cited most
Across all Nikao observations on file
- 21 CFR 803.17(a)(3)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.120Device labeling1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.30(i)Design controls1
The complete Nikao file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Weston, Florida
One Form 483 · 2022 · 6 observations
Latest: Form 483, Feb 18, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-02-18 | 483 Form 483 | Weston, Florida | 6 | $99 |
Investigators on these documents
FEI number 3005687068 · most recent document Feb 18, 2022
About Nikao, Inc
How many FDA Form 483s has Nikao, Inc received?
FDA Intel has 1 Form 483 on file for Nikao, Inc; the most recent is dated Feb 18, 2022.
When was Nikao, Inc last inspected by FDA?
The most recent FDA inspection document on file for Nikao, Inc is a Form 483 dated Feb 18, 2022, for the site in Weston, Florida.
What did FDA cite at Nikao, Inc?
The regulations cited most in the observations on file for Nikao, Inc are 21 CFR 803.17(a)(3) (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.120 (Device labeling), 1 time.