QuVa Pharma, Inc.
Form 483 issued October 14, 2022 · Bloomsbury, New Jersey
- Inspection
- Aug 16 – Oct 14, 2022
- Investigators
- Annet R. Rajan· Helen Verdel· Janet A. Rajan
- Observations
- 5
- Pages
- 8
- FEI number
- 3013931875
In short: On October 14, 2022, FDA issued a Form 483 with 5 observations to QuVa Pharma, Inc. in Bloomsbury, New Jersey (FEI 3013931875) after an inspection that ran Aug 16 – Oct 14, 2022. The investigators were Annet R. Rajan, Helen Verdel and Janet A. Rajan. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 4 of 5 observations.
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 whether or not the batch…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmQuVa Pharma, 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 QuVa Pharma, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected QuVa Pharma, Inc.?
Annet R. Rajan, Helen Verdel and Janet A. Rajan are named on this Form 483, for the inspection of Aug 16 – Oct 14, 2022. Each investigator has a profile showing what they cite most.
When was QuVa Pharma, Inc. inspected by FDA?
The inspection ran Aug 16 – Oct 14, 2022, and the Form 483 is dated October 14, 2022.
How do I get the full Form 483 for QuVa Pharma, 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.