QuVa Pharma, Inc.
FDA inspection history across 3 sites, 2017 to 2025
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one Form 483; 2019: one Form 483; 2022: one Form 483; 2024: one warning letter; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Bloomsbury, New Jersey and Bl oomsbury, New Jersey.
- 2019The longest 483 on file: 6 observations over 4 pages at Bl oomsbury, New Jersey.
- 2022–25Two Form 483s and one warning letter, at Bloomsbury, New Jersey and Sugar Land, Texas.
Cited most
Across all QuVa Pharma observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.165(d)Testing and release for distribution2
- 21 CFR 211.192Production record review2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.56(b)Sanitation2
The complete QuVa Pharma file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Bloomsbury, New Jersey
Three Form 483s · 2017 to 2025 · 12 observations
Latest: Form 483, Apr 4, 2025 →Sugar Land, Texas
One warning letter · 2024
Latest: Warning letter, Jan 26, 2024 →Bl oomsbury, New Jersey
One Form 483 · 2019 · 6 observations
Latest: Form 483, May 31, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-04 | 483 Form 483 | Bloomsbury, New Jersey | 5 | $99 |
| 2024-01-26 | Warning letter Warning letter | Sugar Land, Texas | — | $99 |
| 2022-10-14 | 483 Form 483 | Bloomsbury, New Jersey | 5 | $99 |
| 2019-05-31 | 483 Form 483 | Bl oomsbury, New Jersey | 6 | $99 |
| 2017-11-30 | 483 Form 483 | Bloomsbury, New Jersey | 2 | $99 |
Investigators on these documents
Annet R. Rajan (1)Guerlain Ulysse (1)Helen Verdel (1)Janet A. Rajan (1)Logan T. Williams (1)Tonia F. Bernard (1)Zakaria I. Ganiyu (1)
FEI number 3013931875 · most recent document Apr 4, 2025
About QuVa Pharma, Inc.
How many FDA Form 483s has QuVa Pharma, Inc. received?
FDA Intel has 4 Form 483s on file for QuVa Pharma, Inc.; the most recent is dated Apr 4, 2025.
When was QuVa Pharma, Inc. last inspected by FDA?
The most recent FDA inspection document on file for QuVa Pharma, Inc. is a Form 483 dated Apr 4, 2025, for the site in Bloomsbury, New Jersey.
What did FDA cite at QuVa Pharma, Inc.?
The regulations cited most in the observations on file for QuVa Pharma, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.165(d) (Testing and release for distribution), 2 times; 21 CFR 211.192 (Production record review), 2 times.
Has QuVa Pharma, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for QuVa Pharma, Inc.; the most recent is dated Jan 26, 2024.