FDA-Inspected Site

Sparhawk Laboratories, Inc.

22 FDA inspections are on record for Sparhawk Laboratories, Inc. in Lenexa, United States.

483· Form 483 issued

Lenexa, United States · Last updated July 10, 2026

Overview

  • 22 FDA inspections are on record.
  • 13 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-07-17.

At a glance

Inspections

22

Form 483s

13

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Jul 2025 – 17 Jul 2025Animal Drugs & Feeds483On file
29 Apr 2025 – 9 May 2025Animal Drugs & Feeds483On file
16 Mar 2021 – 23 Mar 2021Animal Drugs & Feeds483On file
18 Feb 2020 – 28 Feb 2020Animal Drugs & Feeds483On file
17 Feb 2020 – 28 Feb 2020Animal Drugs & Feeds483On file
15 Oct 2018 – 29 Oct 2018Animal Drugs & Feeds483On file
6 Oct 2016 – 21 Oct 2016Animal Drugs & Feeds483On file
2 Feb 2015 – 12 Feb 2015Animal Drugs & Feeds483On file
27 Jan 2014 – 31 Jan 2014Animal Drugs & Feeds483On file
27 Apr 2012Not recordedClean
15 Dec 2011Not recordedClean
22 Mar 2011Not recorded483On file

Observations on record

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

23 Mar 2021
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Wayne D Mcgrath, Carl A Huffman, Torrey M Ward

23 Mar 2021
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Wayne D Mcgrath, Carl A Huffman, Torrey M Ward

23 Mar 2021
21 CFR 211.68(b)

Computer control of master formula records

Cited by Wayne D Mcgrath, Carl A Huffman, Torrey M Ward

29 Oct 2018
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Michele L Obert, Laura S Huffman, James K Rice

29 Oct 2018
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Michele L Obert, Laura S Huffman, James K Rice

Investigators

FDA investigators tied to this site in the record.

James K Rice3 insp.
Michele L Obert3 insp.
Jeffrey B Moody3 insp.
Ana Paula P Sandee2 insp.
Victoria A Wagoner2 insp.
Tara L Breckenridge2 insp.
Aerial A Smith1 insp.
Zachary A Bogorad1 insp.
Ashley A Mutawakkil1 insp.
Lisa L Gilliam1 insp.
Susanna E Ford1 insp.
Patricia L Payne1 insp.
Joseph R Lambert1 insp.
Kara L Roden1 insp.
Warren J Lopicka1 insp.
Robin K Reel1 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 observations6x
21 CFR 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.100(b)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited 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 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)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 Sparhawk Laboratories, Inc.'s 13 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

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