Greenfield Global USA Inc
Form 483 issued January 18, 2022 · Brookfield, Connecticut
- Inspection
- Dec 9, 2021 – Jan 18, 2022
- Investigator
- Jonah S. Ufferfilge
- Observations
- 6
- Pages
- 4
- FEI number
- 3004304444
In short: On January 18, 2022, FDA issued a Form 483 with 6 observations to Greenfield Global USA Inc in Brookfield, Connecticut (FEI 3004304444) after an inspection that ran Dec 9, 2021 – Jan 18, 2022. The investigator was Jonah S. Ufferfilge. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your quality unit failed to fully investigate…
- 02
Failure to establish adequate written procedures for cleaning equipment and its release for use in the…
- 03
Failure to use appropriate precautions to minimize the risk of contamination where equipment is opened, or…
- 04
Tire responsibilities applicable to the Quality Control unit are not in writing and/or fully followed. (Repeat…
This inspection in context
Jonah S. Ufferfilge
17 documents · 2019–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
The firmGreenfield Global USA Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Greenfield Global USA Inc?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Greenfield Global USA Inc?
Jonah S. Ufferfilge is named on this Form 483, for the inspection of Dec 9, 2021 – Jan 18, 2022. Each investigator has a profile showing what they cite most.
When was Greenfield Global USA Inc inspected by FDA?
The inspection ran Dec 9, 2021 – Jan 18, 2022, and the Form 483 is dated January 18, 2022.
How do I get the full Form 483 for Greenfield Global USA 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.