C & A Scientific Company, Inc.
Form 483 issued October 16, 2024 · Sterling, Virginia
- Inspection
- Oct 15 – Oct 16, 2024
- Investigator
- Tiki Dixon
- Observations
- 8
- Pages
- 5
- FEI number
- 1000123422
In short: On October 16, 2024, FDA issued a Form 483 with 8 observations to C & A Scientific Company, Inc. in Sterling, Virginia (FEI 1000123422) after an inspection that ran Oct 15 – Oct 16, 2024. The investigator was Tiki Dixon. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 02
Procedures have not been established to control product that does not…
- 03
Procedures for acceptance of incoming product…
- 04
Procedures for corrective and preventive action…
This inspection in context
Tiki Dixon
10 documents · 2016–2024
Cites 820.80(a) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in Virginia.
The firmC & A Scientific Company, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C & A Scientific Company, Inc.?
FDA listed 8 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 C & A Scientific Company, Inc.?
Tiki Dixon is named on this Form 483, for the inspection of Oct 15 – Oct 16, 2024. Each investigator has a profile showing what they cite most.
When was C & A Scientific Company, Inc. inspected by FDA?
The inspection ran Oct 15 – Oct 16, 2024, and the Form 483 is dated October 16, 2024.
How do I get the full Form 483 for C & A Scientific Company, 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.