Azurity Pharmaceuticals, Inc.
Form 483 issued January 15, 2020 · Wilmington, Massachusetts
- Inspection
- Jan 8 – Jan 15, 2020
- Investigator
- Erik W. Koester
- Observations
- 2
- Pages
- 3
- FEI number
- 3003395329
In short: On January 15, 2020, FDA issued a Form 483 with 2 observations to Azurity Pharmaceuticals, Inc. in Wilmington, Massachusetts (FEI 3003395329) after an inspection that ran Jan 8 – Jan 15, 2020. The investigator was Erik W. Koester. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity, specificity and reproducibility of test methods…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmAzurity Pharmaceuticals, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Azurity Pharmaceuticals, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Azurity Pharmaceuticals, Inc.?
Erik W. Koester is named on this Form 483, for the inspection of Jan 8 – Jan 15, 2020. Each investigator has a profile showing what they cite most.
When was Azurity Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 8 – Jan 15, 2020, and the Form 483 is dated January 15, 2020.
How do I get the full Form 483 for Azurity 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.