Aurolife Pharma LLC
Form 483 issued October 22, 2019 · Dayton, New Jersey
- Inspection
- Sep 20 – Oct 22, 2019
- Investigators
- Frederick Razzaghi· Yong Wu
- Observations
- 8
- Pages
- 4
- FEI number
- 3005796917
In short: On October 22, 2019, FDA issued a Form 483 with 8 observations to Aurolife Pharma LLC in Dayton, New Jersey (FEI 3005796917) after an inspection that ran Sep 20 – Oct 22, 2019. The investigators were Frederick Razzaghi and Yong Wu. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 7 of 8 observations.
Most cited: 21 CFR 211.22 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Responsibilities of the quality…
- 02
Laboratory records do not include complete records of testing and standardization…
- 03
Control procedures are not established which monitor the output, validate the performance of those manufacturing processes…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmAurolife Pharma LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurolife Pharma LLC?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Aurolife Pharma LLC?
Frederick Razzaghi and Yong Wu are named on this Form 483, for the inspection of Sep 20 – Oct 22, 2019. Each investigator has a profile showing what they cite most.
When was Aurolife Pharma LLC inspected by FDA?
The inspection ran Sep 20 – Oct 22, 2019, and the Form 483 is dated October 22, 2019.
How do I get the full Form 483 for Aurolife 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.