NEW LIFE DIAGNOSTICS LLC
Form 483 issued February 27, 2019 · Carlsbad, California
- Inspection
- Feb 25 – Feb 27, 2019
- Investigators
- Christine I. Shaw· Marcia G. Evans
- Observations
- 5
- Pages
- 5
- FEI number
- 3011527950
In short: On February 27, 2019, FDA issued a Form 483 with 5 observations to NEW LIFE DIAGNOSTICS LLC in Carlsbad, California (FEI 3011527950) after an inspection that ran Feb 25 – Feb 27, 2019. The investigators were Christine I. Shaw and Marcia G. Evans. Most observations concern production & process controls and cAPA.
At a glance
4 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 02
Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have…
- 03
Acceptance activities were not…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Christine I. Shaw
8 documents · 2016–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Colorado.
The firmNEW LIFE DIAGNOSTICS LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NEW LIFE DIAGNOSTICS LLC?
FDA listed 5 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected NEW LIFE DIAGNOSTICS LLC?
Christine I. Shaw and Marcia G. Evans are named on this Form 483, for the inspection of Feb 25 – Feb 27, 2019. Each investigator has a profile showing what they cite most.
When was NEW LIFE DIAGNOSTICS LLC inspected by FDA?
The inspection ran Feb 25 – Feb 27, 2019, and the Form 483 is dated February 27, 2019.
How do I get the full Form 483 for NEW LIFE DIAGNOSTICS LLC?
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.