Form 483 · FEI 3002889358
Form 483 issued August 21, 2020 · Branchburg, New Jersey
- Inspection
- Jul 27 – Aug 21, 2020
- Investigators
- Ko U. Min· Tamil Arasu
- Observations
- 2
- Pages
- 6
- FEI number
- 3002889358
In short: On August 21, 2020, 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 27 – Aug 21, 2020. The investigators were Ko U. Min and Tamil Arasu. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
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 thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate lest procedures designed to…
This inspection in context
Ko U. Min
13 documents · 2017–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New Jersey.
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 211.192
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 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Ko U. Min and Tamil Arasu are named on this Form 483, for the inspection of Jul 27 – Aug 21, 2020. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 27 – Aug 21, 2020, and the Form 483 is dated August 21, 2020.
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.