Fieldtex Products, Inc
Form 483 issued October 4, 2022 · Rochester, New York
- Inspection
- Sep 30 – Oct 4, 2022
- Investigator
- Matthew D. Schnittker
- Observations
- 8
- Pages
- 5
- FEI number
- 3000215374
In short: On October 4, 2022, FDA issued a Form 483 with 8 observations to Fieldtex Products, Inc in Rochester, New York (FEI 3000215374) after an inspection that ran Sep 30 – Oct 4, 2022. The investigator was Matthew D. Schnittker. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 02
Procediues have not been adequately established to control product that does not…
- 03
Procedures for collective and preventive action have…
- 04
Process control procedures that describe any process controls necessary to ensure conformance to specifications…
This inspection in context
Matthew D. Schnittker
12 documents · 2015–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmFieldtex Products, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fieldtex Products, Inc?
FDA listed 8 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Fieldtex Products, Inc?
Matthew D. Schnittker is named on this Form 483, for the inspection of Sep 30 – Oct 4, 2022. Each investigator has a profile showing what they cite most.
When was Fieldtex Products, Inc inspected by FDA?
The inspection ran Sep 30 – Oct 4, 2022, and the Form 483 is dated October 4, 2022.
How do I get the full Form 483 for Fieldtex Products, 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.