Niagara Pharmaceuticals, Inc
Form 483 issued April 25, 2022 · Dundas, Canada
- Inspection
- Apr 18 – Apr 25, 2022
- Investigator
- Alan P. Kurtzberg
- Observations
- 4
- Pages
- 2
- FEI number
- 3003093882
In short: On April 25, 2022, FDA issued a Form 483 with 4 observations to Niagara Pharmaceuticals, Inc in Dundas, Ontario (FEI 3003093882) after an inspection that ran Apr 18 – Apr 25, 2022. The investigator was Alan P. Kurtzberg. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
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
The number of containers to be sampled is not…
- 03
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and…
- 04
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmNiagara Pharmaceuticals, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Niagara Pharmaceuticals, Inc?
FDA listed 4 observations on this Form 483, mostly about production, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Niagara Pharmaceuticals, Inc?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Apr 18 – Apr 25, 2022. Each investigator has a profile showing what they cite most.
When was Niagara Pharmaceuticals, Inc inspected by FDA?
The inspection ran Apr 18 – Apr 25, 2022, and the Form 483 is dated April 25, 2022.
How do I get the full Form 483 for Niagara 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.