US Pharmaceuticals Inc
Form 483 issued October 16, 2020 · Belleville, New Jersey
- Inspection
- Oct 6 – Oct 16, 2020
- Investigators
- Guerlain Ulysse· Robin P. Mathew
- Observations
- 4
- Pages
- 6
- FEI number
- 3008275696
In short: On October 16, 2020, FDA issued a Form 483 with 4 observations to US Pharmaceuticals Inc in Belleville, New Jersey (FEI 3008275696) after an inspection that ran Oct 6 – Oct 16, 2020. The investigators were Guerlain Ulysse and Robin P. Mathew. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 04
Your master production and control records for each drug product were not prepared, dated, and signed…
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 4 observations on this Form 483, mostly about quality system and production. 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 US Pharmaceuticals Inc?
Guerlain Ulysse and Robin P. Mathew are named on this Form 483, for the inspection of Oct 6 – Oct 16, 2020. Each investigator has a profile showing what they cite most.
When was US Pharmaceuticals Inc inspected by FDA?
The inspection ran Oct 6 – Oct 16, 2020, and the Form 483 is dated October 16, 2020.
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.