Biodex Medical Systems, Inc
FDA inspection history in Shirley, New York, 2015 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Shirley, New York.
- 2015The longest 483 on file: 5 observations over 3 pages at Shirley, New York.
- 2023One Form 483, at Shirley, New York.
Cited most
Across all Biodex Medical Systems observations on file
- 21 CFR 820.184Device history record2
- 21 CFR 820.120(b)Device labeling1
- 21 CFR 820.40(b)Document controls1
- 21 CFR 820.65Traceability1
- 21 CFR 820.70(a)Production and process controls1
The complete Biodex Medical Systems file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Shirley, New York
Two Form 483s · 2015 to 2023 · 7 observations
Latest: Form 483, Feb 10, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-02-10 | 483 Form 483 | Shirley, New York | 2 | $99 |
| 2015-03-18 | 483 Form 483 | Shirley, New York | 5 | $99 |
Investigators on these documents
FEI number 2431314 · most recent document Feb 10, 2023
About Biodex Medical Systems, Inc
How many FDA Form 483s has Biodex Medical Systems, Inc received?
FDA Intel has 2 Form 483s on file for Biodex Medical Systems, Inc; the most recent is dated Feb 10, 2023.
When was Biodex Medical Systems, Inc last inspected by FDA?
The most recent FDA inspection document on file for Biodex Medical Systems, Inc is a Form 483 dated Feb 10, 2023, for the site in Shirley, New York.
What did FDA cite at Biodex Medical Systems, Inc?
The regulations cited most in the observations on file for Biodex Medical Systems, Inc are 21 CFR 820.184 (Device history record), 2 times; 21 CFR 820.120(b) (Device labeling), 1 time; 21 CFR 820.40(b) (Document controls), 1 time.