US Pharmaceuticals Inc
Form 483 issued December 18, 2018 · Belleville, New Jersey
- Inspection
- Oct 31 – Dec 18, 2018
- Investigators
- Guerlain Ulysse· Monika Borkowska
- Observations
- 6
- Pages
- 8
- FEI number
- 3008275696
In short: On December 18, 2018, FDA issued a Form 483 with 6 observations to US Pharmaceuticals Inc in Belleville, New Jersey (FEI 3008275696) after an inspection that ran Oct 31 – Dec 18, 2018. The investigators were Guerlain Ulysse and Monika Borkowska. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written records of investigation of a drug complaint do not include the…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmUS Pharmaceuticals Inc history
All 4 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 US Pharmaceuticals Inc?
FDA listed 6 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected US Pharmaceuticals Inc?
Guerlain Ulysse and Monika Borkowska are named on this Form 483, for the inspection of Oct 31 – Dec 18, 2018. Each investigator has a profile showing what they cite most.
When was US Pharmaceuticals Inc inspected by FDA?
The inspection ran Oct 31 – Dec 18, 2018, and the Form 483 is dated December 18, 2018.
How do I get the full Form 483 for US Pharmaceuticals 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.