Centrix, Inc
Form 483 issued March 2, 2022 · Shelton, Connecticut
- Inspection
- Feb 9 – Mar 2, 2022
- Investigator
- Samir C. Gala
- Observations
- 6
- Pages
- 6
- FEI number
- 1281412
In short: On March 2, 2022, FDA issued a Form 483 with 6 observations to Centrix, Inc in Shelton, Connecticut (FEI 1281412) after an inspection that ran Feb 9 – Mar 2, 2022. The investigator was Samir C. Gala. Most observations concern laboratory controls and materials.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Each container or grouping of containers of components is not examined visually upon receipt and before…
- 03
Strict control is not exercised over labeling issued for use in…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Samir C. Gala
10 documents · 2020–2024
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Connecticut.
The firmCentrix, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Centrix, Inc?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, materials and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Centrix, Inc?
Samir C. Gala is named on this Form 483, for the inspection of Feb 9 – Mar 2, 2022. Each investigator has a profile showing what they cite most.
When was Centrix, Inc inspected by FDA?
The inspection ran Feb 9 – Mar 2, 2022, and the Form 483 is dated March 2, 2022.
How do I get the full Form 483 for Centrix, 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.