Atlas

FDA-Inspected Site

QuVa Pharma, Inc.

9 FDA inspections are on record for QuVa Pharma, Inc. in Temple, United States.

483· Form 483 issued

Temple, United States · Last updated July 10, 2026

Overview

  • 9 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-06-16.

At a glance

Inspections

9

Form 483s

7

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
7 Jun 2022 – 16 Jun 2022Human Drugs483View 483 →
26 Feb 2019 – 14 Mar 2019Human Drugs483On file
16 Apr 2018 – 20 Apr 2018Human Drugs483View 483 →
28 Nov 2016 – 8 Dec 2016Human Drugs483View 483 →
13 Jan 2015 – 23 Jan 2015Human Drugs483View 483 →
9 Jun 2014 – 20 Jun 2014Human Drugs483On file
17 Mar 2014 – 2 Apr 2014Human Drugs483On file
22 Aug 2003Not recordedClean
5 Sep 2000Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

16 Jun 2022
21 CFR 211.186(b)(9)

Manufacturing Instructions and Specifications

Cited by Camerson E Moore, Damaris Y Hernandez

16 Jun 2022
21 CFR 211.42(c)(10)(i)

Floors, walls, ceiling surfaces

Cited by Camerson E Moore, Damaris Y Hernandez

16 Jun 2022
21 CFR 211.68(b)

input/output verification

Cited by Camerson E Moore, Damaris Y Hernandez

20 Apr 2018
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Scott T Ballard

20 Apr 2018
21 CFR 211.198(b)(2)

Written record of complaint to include findings, follow-up

Cited by Scott T Ballard

Investigators

FDA investigators tied to this site in the record.

Scott T Ballard3 insp.
Stephen D Brown2 insp.
Camerson E Moore1 insp.
Damaris Y Hernandez1 insp.
Margaret M Annes1 insp.
Aqualia L Nelson1 insp.
Lisa R Whitt1 insp.
Ademola O Daramola1 insp.
Patrice S Hall1 insp.
Andrea A Branche1 insp.
Darla J Christopher1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(iii)Cited across public-safe Form 483 observations2x
FDCA 503B(a)(10)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(i)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind QuVa Pharma, Inc.'s 7 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat