Centrix, Inc
Form 483 issued January 31, 2017 · Shelton, Connecticut
- Inspection
- Jan 5 – Jan 31, 2017
- Investigator
- Dien N. Nguyen
- Observations
- 8
- Pages
- 5
- FEI number
- 1281412
In short: On January 31, 2017, FDA issued a Form 483 with 8 observations to Centrix, Inc in Shelton, Connecticut (FEI 1281412) after an inspection that ran Jan 5 – Jan 31, 2017. The investigator was Dien N. Nguyen. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 5 of 8 observations.
Most cited: 21 CFR 211.100(b) (2×)
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 upon receipt and before acceptance…
- 03
Master production and control records lack a statement of theoretical yield including the maximum and minimum…
- 04
Deviations from written production and process control procedures are…
This inspection in context
Dien N. Nguyen
6 documents · 2016–2018
Cites 211.113 (control of microbiological contamination) 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 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Centrix, Inc?
FDA listed 8 observations on this Form 483, mostly about production, laboratory controls and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Centrix, Inc?
Dien N. Nguyen is named on this Form 483, for the inspection of Jan 5 – Jan 31, 2017. Each investigator has a profile showing what they cite most.
When was Centrix, Inc inspected by FDA?
The inspection ran Jan 5 – Jan 31, 2017, and the Form 483 is dated January 31, 2017.
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.