Bergen Medical Products, Inc
FDA inspection history in Morris Plains, New Jersey, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Morris Plains, New Jersey.
Cited most
Across all Bergen Medical Products observations on file
- 21 CFR 820.198Complaint files1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.30(j)Design controls1
The complete Bergen Medical Products file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Morris Plains, New Jersey
One Form 483 · 2019 · 3 observations
Latest: Form 483, Sep 11, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-11 | 483 Form 483 | Morris Plains, New Jersey | 3 | $99 |
Investigators on these documents
FEI number 3013449622 · most recent document Sep 11, 2019
About Bergen Medical Products, Inc
How many FDA Form 483s has Bergen Medical Products, Inc received?
FDA Intel has 1 Form 483 on file for Bergen Medical Products, Inc; the most recent is dated Sep 11, 2019.
When was Bergen Medical Products, Inc last inspected by FDA?
The most recent FDA inspection document on file for Bergen Medical Products, Inc is a Form 483 dated Sep 11, 2019, for the site in Morris Plains, New Jersey.
What did FDA cite at Bergen Medical Products, Inc?
The regulations cited most in the observations on file for Bergen Medical Products, Inc are 21 CFR 820.198 (Complaint files), 1 time; 21 CFR 820.20(c) (Management responsibility), 1 time; 21 CFR 820.30(j) (Design controls), 1 time.