Us,Organic Group Corp
Form 483 issued March 18, 2016 · Passaic, New Jersey
- Inspection
- Mar 9 – Mar 18, 2016
- Investigators
- Helen Verdel· Melissa T. Roy
- Observations
- 7
- Pages
- 4
- FEI number
- 3012119852
In short: On March 18, 2016, FDA issued a Form 483 with 7 observations to Us,Organic Group Corp in Passaic, New Jersey (FEI 3012119852) after an inspection that ran Mar 9 – Mar 18, 2016. The investigators were Helen Verdel and Melissa T. Roy. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Individuals responsible for supervising the manufacture , processing , packing and holding of a drug product…
- 02
Buildings used in the manufacturing , processing , packing and holding of a drug product are…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Helen Verdel
13 documents · 2015–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmUs,Organic Group Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Us,Organic Group Corp?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Us,Organic Group Corp?
Helen Verdel and Melissa T. Roy are named on this Form 483, for the inspection of Mar 9 – Mar 18, 2016. Each investigator has a profile showing what they cite most.
When was Us,Organic Group Corp inspected by FDA?
The inspection ran Mar 9 – Mar 18, 2016, and the Form 483 is dated March 18, 2016.
How do I get the full Form 483 for Us,Organic Group Corp?
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.