Novum Pharma, LLC
Form 483 issued September 24, 2019 · Chicago, Illinois
- Inspection
- Jun 4 – Sep 24, 2019
- Investigators
- Alan M. Roberts· Nicholas P. Diorio
- Observations
- 7
- Pages
- 13
- FEI number
- 3013162819
In short: On September 24, 2019, FDA issued a Form 483 with 7 observations to Novum Pharma, LLC in Chicago, Illinois (FEI 3013162819) after an inspection that ran Jun 4 – Sep 24, 2019. The investigators were Alan M. Roberts and Nicholas P. Diorio. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
6 of 7 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 quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed, packed and…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
Serious, unexpected adverse drug experiences…
This inspection in context
Alan M. Roberts
4 documents · 2019–2021
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmNovum Pharma, LLC history
The site's inspection history, in date order.
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 Novum Pharma, LLC?
FDA listed 7 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Novum Pharma, LLC?
Alan M. Roberts and Nicholas P. Diorio are named on this Form 483, for the inspection of Jun 4 – Sep 24, 2019. Each investigator has a profile showing what they cite most.
When was Novum Pharma, LLC inspected by FDA?
The inspection ran Jun 4 – Sep 24, 2019, and the Form 483 is dated September 24, 2019.
How do I get the full Form 483 for Novum Pharma, LLC?
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.