James Consolidated, Inc
Form 483 issued November 3, 2020 · Concord, California
- Inspection
- Oct 27 – Nov 3, 2020
- Investigators
- Christopher W. Buser· Harjap K. Atwal· Jeffrey S. Buckser
- Observations
- 10
- Pages
- 7
- FEI number
- 2939266
In short: On November 3, 2020, FDA issued a Form 483 with 10 observations to James Consolidated, Inc in Concord, California (FEI 2939266) after an inspection that ran Oct 27 – Nov 3, 2020. The investigators were Christopher W. Buser, Harjap K. Atwal, Jeffrey S. Buckser and Maida Henesian. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action…
- 02
A device master record…
- 03
Procedures for quality audits…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Christopher W. Buser
1 document · 2020
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in California.
The firmJames Consolidated, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at James Consolidated, Inc?
FDA listed 10 observations on this Form 483, mostly about cAPA, management controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected James Consolidated, Inc?
Christopher W. Buser, Harjap K. Atwal, Jeffrey S. Buckser and Maida Henesian are named on this Form 483, for the inspection of Oct 27 – Nov 3, 2020. Each investigator has a profile showing what they cite most.
When was James Consolidated, Inc inspected by FDA?
The inspection ran Oct 27 – Nov 3, 2020, and the Form 483 is dated November 3, 2020.
How do I get the full Form 483 for James Consolidated, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.