Oxford Performance Materials, Inc
Form 483 issued April 7, 2017 · South Windsor, Connecticut
- Inspection
- Mar 28 – Apr 7, 2017
- Investigator
- Jeffrey J. Thibodeau
- Observations
- 5
- Pages
- 3
- FEI number
- 3009582362
In short: On April 7, 2017, FDA issued a Form 483 with 5 observations to Oxford Performance Materials, Inc in South Windsor, Connecticut (FEI 3009582362) after an inspection that ran Mar 28 – Apr 7, 2017. The investigator was Jeffrey J. Thibodeau. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
5 of 5 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for the use and removal of manufacturing material…
- 03
Procedures to control environmental conditions…
- 04
Process validation results have not been…
This inspection in context
Jeffrey J. Thibodeau
7 documents · 2015–2024
Cites 820.70(b) (production and process controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmOxford Performance Materials, 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 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oxford Performance Materials, Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Oxford Performance Materials, Inc?
Jeffrey J. Thibodeau is named on this Form 483, for the inspection of Mar 28 – Apr 7, 2017. Each investigator has a profile showing what they cite most.
When was Oxford Performance Materials, Inc inspected by FDA?
The inspection ran Mar 28 – Apr 7, 2017, and the Form 483 is dated April 7, 2017.
How do I get the full Form 483 for Oxford Performance Materials, 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.