Overview
- 14 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-22.
At a glance
Inspections
14
Form 483s
4
EIRs
4
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Apr 2026 | Biologics | Clean | |
| 18 Nov 2025 – 21 Nov 2025 | Human Drugs | Clean | |
| 19 Sep 2022 – 21 Sep 2022 | Human Drugs | 483 | On file |
| 20 Dec 2021 – 28 Jan 2022 | Human Drugs | 483 | View 483 → |
| 23 Apr 2019 – 24 Apr 2019 | Human Drugs | 483 | View 483 → |
| 8 Aug 2018 – 13 Aug 2018 | Medical Devices & Rad Health | Clean | |
| 1 Feb 2017 – 3 Feb 2017 | Human Drugs | Clean | |
| 18 Jun 2014 – 19 Jun 2014 | Medical Devices & Rad Health | Clean | |
| 9 Jan 2014 – 15 Jan 2014 | Human Drugs | 483 | View 483 → |
| 15 Feb 2013 – 21 Feb 2013 | Medical Devices & Rad Health | Clean | |
| 23 Jan 2012 | Not recorded | Clean | |
| 13 Apr 2011 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jan 2022
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Yvins Dezan, Jessica S Estriplet
28 Jan 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Yvins Dezan, Jessica S Estriplet
28 Jan 2022
21 CFR 211.125(d)
Destruction of excess labels with lot numbers
Cited by Yvins Dezan, Jessica S Estriplet
28 Jan 2022
21 CFR 211.130(e)
Packaging line inspection before use
Cited by Yvins Dezan, Jessica S Estriplet
28 Jan 2022
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Yvins Dezan, Jessica S Estriplet
Investigators
FDA investigators tied to this site in the record.
Christina K Theodorou3 insp.
James M Mason3 insp.
Brian S Keefer2 insp.
Edward D Mcdonald2 insp.
Michele Gottshall1 insp.
Zhong Li1 insp.
Esther C Broner1 insp.
Yvins Dezan1 insp.
Jessica S Estriplet1 insp.
Craig D Zagata1 insp.
Daniel T Lee1 insp.
Cara M Minelli1 insp.
Charlotte E Wilkins1 insp.
Michael A Taylor1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sharp Packaging Services, LLC's 4 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