Atlas

FDA-Inspected Site

DAVA Pharmaceuticals, Inc.

5 FDA inspections are on record for DAVA Pharmaceuticals, Inc. in Fort Lee, United States.

Clean· No action indicated

Fort Lee, United States · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2014-06-23.

At a glance

Inspections

5

Form 483s

3

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Jun 2014 – 23 Jun 2014Human DrugsClean
6 Jul 2012Not recorded483View 483 →
3 Mar 2011Not recorded483View 483 →
18 Apr 2008Not recorded483On file
21 Aug 2007Not recordedClean

Observations on record

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

6 Jul 2012
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Liatte Krueger, Melba T Rivera Clavell

6 Jul 2012
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Liatte Krueger, Melba T Rivera Clavell

6 Jul 2012
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Liatte Krueger, Melba T Rivera Clavell

6 Jul 2012
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Liatte Krueger, Melba T Rivera Clavell

6 Jul 2012
21 CFR 314.80(c)(2)

Interval

Cited by Liatte Krueger, Melba T Rivera Clavell

Investigators

FDA investigators tied to this site in the record.

Stephen J Mottola1 insp.
Liatte Krueger1 insp.
Melba T Rivera Clavell1 insp.
Helen Verdel1 insp.
Kelli F Dobilas1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind DAVA Pharmaceuticals, Inc.'s 3 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