Atlas

FDA-Inspected Site

Altaire Pharmaceuticals, Inc.

19 FDA inspections are on record for Altaire Pharmaceuticals, Inc. in Aquebogue, United States.

483· Form 483 issued

Aquebogue, United States · Last updated August 15, 2026

Overview

  • 19 FDA inspections are on record.
  • 14 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-21.

At a glance

Inspections

19

Form 483s

14

EIRs

4

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Mar 2026 – 21 Apr 2026Human Drugs483View 483 →
21 Oct 2024Medical Devices & Rad HealthClean
14 Sep 2021 – 11 Feb 2022Human Drugs483On file
25 Mar 2019 – 19 Apr 2019Human DrugsWLView 483 →
27 Feb 2017 – 9 Mar 2017Human Drugs483View 483 →
30 Nov 2015 – 15 Dec 2015Human Drugs483View 483 →
31 Mar 2015 – 13 Apr 2015Human Drugs483View 483 →
14 Jul 2014 – 29 Jul 2014Human Drugs483View 483 →
22 Jul 2013 – 8 Aug 2013Human Drugs483View 483 →
7 Jun 2012Not recorded483View 483 →
19 Mar 2012Not recorded483View 483 →
19 Nov 2010Not recorded483View 483 →

Observations on record

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

21 Apr 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Bijoy Panicker

21 Apr 2026
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Bijoy Panicker

21 Apr 2026
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Bijoy Panicker

21 Apr 2026
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Bijoy Panicker

21 Apr 2026
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Bijoy Panicker

Investigators

FDA investigators tied to this site in the record.

Robert C Horan11 insp.
Bijoy Panicker3 insp.
Gary J Lehr2 insp.
Jacqueline S Warner1 insp.
Juanita P Versace1 insp.
Jazmine N Brown1 insp.
Avital A Shimanovich1 insp.
Edmund F Mrak1 insp.
Sarah A Wangseng1 insp.
Parul M Patel1 insp.
Charisse K Green1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations16x
21 CFR 211.160(b)Cited across public-safe Form 483 observations13x
21 CFR 211.22(d)Cited across public-safe Form 483 observations12x
21 CFR 211.110(a)Cited across public-safe Form 483 observations8x
21 CFR 211.68(b)Cited across public-safe Form 483 observations8x
21 CFR 211.25(a)Cited across public-safe Form 483 observations5x
21 CFR 211.100(a)Cited across public-safe Form 483 observations4x
21 CFR 211.160(a)Cited across public-safe Form 483 observations4x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations4x
21 CFR 211.194(a)Cited across public-safe Form 483 observations4x
21 CFR 211.198(a)Cited across public-safe Form 483 observations4x
21 CFR 211.28(a)Cited across public-safe Form 483 observations4x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations4x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations4x
21 CFR 211.67(a)Cited across public-safe Form 483 observations4x
21 CFR 211.125(a)Cited across public-safe Form 483 observations3x
21 CFR 211.142(b)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 211.170(b)Cited across public-safe Form 483 observations3x
21 CFR 211.188(a)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(vi)Cited across public-safe Form 483 observations3x
21 CFR 211.56(a)Cited across public-safe Form 483 observations3x
21 CFR 211.63Cited across public-safe Form 483 observations3x
21 CFR 211.67(b)(2)Cited across public-safe Form 483 observations3x
21 CFR 211.67(b)(5)Cited across public-safe Form 483 observations3x
21 CFR 211.68(a)Cited across public-safe Form 483 observations3x
21 CFR 211.113(a)Cited across public-safe Form 483 observations2x
21 CFR 211.165(e)Cited across public-safe Form 483 observations2x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations2x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.80(a)Cited across public-safe Form 483 observations2x
21 CFR 211.87Cited across public-safe Form 483 observations2x
21 CFR 111.325(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(d)Cited across public-safe Form 483 observations1x
21 CFR 211.130(a)Cited across public-safe Form 483 observations1x
21 CFR 211.130(b)Cited across public-safe Form 483 observations1x
21 CFR 211.130(d)Cited across public-safe Form 483 observations1x
21 CFR 211.130(e)Cited across public-safe Form 483 observations1x
21 CFR 211.142Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.204Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Altaire Pharmaceuticals, Inc.'s 14 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