LC Technologies, Incorporated
Form 483 issued April 23, 2015 · Fairfax, Virginia
- Inspection
- Apr 7 – Apr 23, 2015
- Investigator
- Erin L. McFiren
- Observations
- 9
- Pages
- 4
- FEI number
- 1000123308
In short: On April 23, 2015, FDA issued a Form 483 with 9 observations to LC Technologies, Incorporated in Fairfax, Virginia (FEI 1000123308) after an inspection that ran Apr 7 – Apr 23, 2015. The investigator was Erin L. McFiren. Most observations concern records & documents and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by records & documents.
Most cited: 21 CFR 820.30 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design change have…
- 02
Results of the design risk…
- 03
Complaint files are not…
- 04
Procedures for corrective and preventive action…
This inspection in context
Erin L. McFiren
1 document · 2015
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Virginia.
The firmLC Technologies, Incorporated history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LC Technologies, Incorporated?
FDA listed 9 observations on this Form 483, mostly about records & documents, design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected LC Technologies, Incorporated?
Erin L. McFiren is named on this Form 483, for the inspection of Apr 7 – Apr 23, 2015. Each investigator has a profile showing what they cite most.
When was LC Technologies, Incorporated inspected by FDA?
The inspection ran Apr 7 – Apr 23, 2015, and the Form 483 is dated April 23, 2015.
How do I get the full Form 483 for LC Technologies, Incorporated?
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.