Azurity Pharmaceuticals, Inc.
Form 483 issued March 2, 2023 · Wilmington, Massachusetts
- Inspection
- Feb 2 – Mar 2, 2023
- Investigator
- Robert J. Martin
- Observations
- 5
- Pages
- 9
- FEI number
- 3003395329
In short: On March 2, 2023, FDA issued a Form 483 with 5 observations to Azurity Pharmaceuticals, Inc. in Wilmington, Massachusetts (FEI 3003395329) after an inspection that ran Feb 2 – Mar 2, 2023. The investigator was Robert J. Martin. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 4 of 5 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
The written stability program does not assure testing of the drug product in the same container-closure…
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Azurity Pharmaceuticals, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls 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 Azurity Pharmaceuticals, Inc.?
Robert J. Martin is named on this Form 483, for the inspection of Feb 2 – Mar 2, 2023. Each investigator has a profile showing what they cite most.
When was Azurity Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Feb 2 – Mar 2, 2023, and the Form 483 is dated March 2, 2023.
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.