Form 483

QuVa Pharma, Inc. Form 483, 2025-04-04

FDA issued a Form 483 to QuVa Pharma, Inc. on 2025-04-04 with 5 public-safe observations.

483· Form 483 issuedHuman Drugs5 observations

QuVa Pharma, Inc. · Bloomsbury, United States · Issued April 4, 2025

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

4 Apr 2025
21 CFR 211.165(d)

Acceptance/Rejection Levels

Cited by Logan T Williams

4 Apr 2025
21 CFR 211.165(e)

Test methods

Cited by Logan T Williams

4 Apr 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Logan T Williams

4 Apr 2025
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Logan T Williams

4 Apr 2025
21 CFR 211.56(b)

Written sanitation procedures not followed

Cited by Logan T Williams

Inspected site

QPQuVa Pharma, Inc.Bloomsbury, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(d)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere