Form 483 · FEI 3002889358
Form 483 issued August 25, 2022 · Branchburg, New Jersey
- Inspection
- Jul 26 – Aug 25, 2022
- Investigators
- Edmund F. Mrak Jr· Kathleen M. Jordan
- Observations
- 2
- Pages
- 2
- FEI number
- 3002889358
In short: On August 25, 2022, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Branchburg, New Jersey (FEI 3002889358) after an inspection that ran Jul 26 – Aug 25, 2022. The investigators were Edmund F. Mrak Jr and Kathleen M. Jordan. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to control the disposition and availability of drug su bstances determined to…
- 02
There is a failure to adequately document, explain, and investigate all deviat ions…
This inspection in context
Edmund F. Mrak Jr
7 documents · 2012–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSite history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Edmund F. Mrak Jr and Kathleen M. Jordan are named on this Form 483, for the inspection of Jul 26 – Aug 25, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 26 – Aug 25, 2022, and the Form 483 is dated August 25, 2022.
How do I get the full Form 483 for an FDA-inspected site?
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.