James Consolidated, Inc
FDA inspection history in Concord, California, 2020
- 1
- Form 483
Every document, by year
- Form 483
2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Concord, California.
Cited most
Across all James Consolidated 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 820.100Corrective and preventive action1
- 21 CFR 820.181Device master record1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.20Management responsibility1
The complete James Consolidated file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Concord, California
One Form 483 · 2020 · 10 observations
Latest: Form 483, Nov 3, 2020 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-11-03 | 483 Form 483 | Concord, California | 10 | $99 |
Investigators on these documents
Christopher W. Buser (1)Harjap K. Atwal (1)Jeffrey S. Buckser (1)Maida Henesian (1)
FEI number 2939266 · most recent document Nov 3, 2020
About James Consolidated, Inc
How many FDA Form 483s has James Consolidated, Inc received?
FDA Intel has 1 Form 483 on file for James Consolidated, Inc; the most recent is dated Nov 3, 2020.
When was James Consolidated, Inc last inspected by FDA?
The most recent FDA inspection document on file for James Consolidated, Inc is a Form 483 dated Nov 3, 2020, for the site in Concord, California.
What did FDA cite at James Consolidated, Inc?
The regulations cited most in the observations on file for James Consolidated, Inc 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 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.181 (Device master record), 1 time.