Azurity Pharmaceuticals, Inc.
FDA inspection history across 3 sites, 2020 to 2024
- 3
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2020: one Form 483; 2022: one Form 483; 2023: one Form 483; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–24Three Form 483s and one warning letter, at Wilmington, Massachusetts and Woburn, Massachusetts.
- 2023The longest 483 on file: 5 observations over 9 pages at Wilmington, Massachusetts.
Cited most
Across all Azurity Pharmaceuticals observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
The complete Azurity Pharmaceuticals file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Wilmington, Massachusetts
Three Form 483s · 2020 to 2023 · 10 observations
Latest: Form 483, Mar 2, 2023 →Woburn, Massachusetts
One warning letter · 2024
Latest: Warning letter, Sep 20, 2024 →Raleigh, North Carolina
One close-out letter
Latest: Close-out, — →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-20 | Warning letter Warning letter | Woburn, Massachusetts | — | $99 |
| 2023-03-02 | 483 Form 483 | Wilmington, Massachusetts | 5 | $99 |
| 2022-02-24 | 483 Form 483 | Wilmington, Massachusetts | 3 | $99 |
| 2020-01-15 | 483 Form 483 | Wilmington, Massachusetts | 2 | $99 |
| Undated | Close-out Close-out letter | Raleigh, North Carolina | — | $99 |
Investigators on these documents
FEI number 3003395329 · most recent document Sep 20, 2024
About Azurity Pharmaceuticals, Inc.
How many FDA Form 483s has Azurity Pharmaceuticals, Inc. received?
FDA Intel has 3 Form 483s on file for Azurity Pharmaceuticals, Inc.; the most recent is dated Mar 2, 2023.
When was Azurity Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Azurity Pharmaceuticals, Inc. is a Form 483 dated Mar 2, 2023, for the site in Wilmington, Massachusetts.
What did FDA cite at Azurity Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for Azurity Pharmaceuticals, Inc. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times.
Has Azurity Pharmaceuticals, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Azurity Pharmaceuticals, Inc.; the most recent is dated Sep 20, 2024.