Overview
- 10 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-05.
At a glance
Inspections
10
Form 483s
10
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Feb 2026 – 5 Mar 2026 | Human Drugs | 483 | View 483 → |
| 14 Oct 2024 – 21 Oct 2024 | Human Drugs | 483 | On file |
| 4 Jun 2024 – 12 Jun 2024 | Biologics | 483 | View 483 → |
| 14 Aug 2023 – 25 Aug 2023 | Human Drugs | 483 | View 483 → |
| 16 Jan 2023 – 20 Jan 2023 | Biologics | 483 | On file |
| 9 May 2022 – 23 May 2022 | Human Drugs | 483 | View 483 → |
| 4 Oct 2021 – 15 Oct 2021 | Human Drugs | 483 | View 483 → |
| 26 Aug 2020 – 27 Oct 2020 | Human Drugs | 483 | View 483 → |
| 24 Sep 2018 – 10 Oct 2018 | Human Drugs | 483 | View 483 → |
| 26 Mar 2018 – 13 Apr 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Mar 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Erik W Koester, Syeda N Mahazabin
5 Mar 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Erik W Koester, Syeda N Mahazabin
5 Mar 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Erik W Koester, Syeda N Mahazabin
5 Mar 2026
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Erik W Koester, Syeda N Mahazabin
Investigators
FDA investigators tied to this site in the record.
Erik W Koester3 insp.
Syeda N Mahazabin1 insp.
Cassandra L Abellard1 insp.
Hamet M Toure1 insp.
Andrea Franco1 insp.
Brentley S Collins1 insp.
Latorie S Jones1 insp.
Brentley S Pittman1 insp.
Jonathan G Matrisciano1 insp.
Jie He1 insp.
Obinna R Echeozo1 insp.
Carl A Perez1 insp.
Mindy M Chou1 insp.
Daniel L Zheng1 insp.
Sony Mathews1 insp.
Rajiv R Srivastava1 insp.
John P Mistler1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 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 211.42(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sharp Sterile Manufacturing, LLC's 10 Form 483s
Source PDFs 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